| The concepts of Statistical Process Control (SPC) were initially developed by Dr. Walter Shewhart of Bell Laboratories in the 1920's, and were expanded upon by Dr. W. Edwards Deming,  who introduced SPC to Japanese industry after WWII.  After early  successful adoption by Japanese firms, Statistical Process Control has  now been incorporated by organizations around the world as a primary  tool to improve product quality by reducing process variation. | 
  | Dr. Shewhart identified two sources of process variation:  Chance variation that is inherent in process, and stable over time, and Assignable, or Uncontrolled  variation, which is unstable over time - the result of specific events  outside the system.  Dr. Deming relabeled chance variation as Common Cause variation, and assignable variation as Special Cause  variation.   Based on experience with many types of process data, and  supported by the laws of statistics and probability, Dr. Shewhart  devised control charts used to plot data over time and identify both  Common Cause variation and Special Cause variation. | 
  | This tutorial provides a brief conceptual  background to the practice of SPC, as well as the necessary formulas and  techniques to apply it. | 
   
  | If you have reviewed the discussion of frequency  distributions in the Histogram module, you will recall that many  histograms will approximate a Normal Distribution, as shown below  (please note that control charts do not require normally distributed data in order to work - they will work with any process distribution - we use a normal distribution in this example for ease of representation): | 
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  | In order to work with any distribution, it is  important to have a measure of the data dispersion, or spread.   This  can be expressed by the range (highest less lowest), but is better  captured by the standard deviation (sigma).  The standard deviation can  be easily calculated from a group of numbers using many calculators, or a  spreadsheet or statistics program. | 
   
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  | Often we focus on average values, but  understanding dispersion is critical to the management of industrial  processes.  Consider two examples: 
 
 |  | If you put one foot in a bucket of ice water (33  degrees F) and one foot in a bucket of scalding water (127 degrees F),  on average you'll feel fine (80 degrees F), but you won't actually be  very comfortable! |   |  | If you are asked to walk through a river and are  told that the average water depth is 3 feet you might want more  information.  If you are then told that the range is from zero to 15  feet, you might want to re-evaluate the trip. |  | 
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| MoreSteam Hint:  Analysis of averages should always be accompanied by analysis of the variability! |  | 
   
  | Statistical tables have been developed for various  types of distributions that quantify the area under the curve for a  given number of standard deviations from the mean (the normal  distribution is shown in this example).  These can be used as  probability tables to calculate the odds that a given value  (measurement) is part of the same group of data used to construct the  histogram.  Shewhart found that control limits placed at three standard  deviations from the mean in either direction provide an economical  tradeoff between the risk of reacting to a false signal and the risk of  not reacting to a true signal - regardless the shape of the underlying  process distribution.   If the process has a normal distribution, 99.7%  of the population is captured by the curve at three standard deviations  from the mean.  Stated another way, there is only a 1-99.7%, or 0.3%  chance of finding a value beyond 3 standard deviations.  Therefore, a  measurement value beyond 3 standard deviations indicates that the  process has either shifted or become unstable (more variability).  The  illustration below shows a normal curve for a distribution with a mean  of 69, a mean less 3 standard deviations value of 63.4, and a  mean plus  3 standard deviations value of 74.6.  Values, or measurements, less  than 63.4 or greater than 74.6 are extremely unlikely.  These laws of  probability are the foundation of the control chart. | 
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  | Now, consider that the distribution is turned  sideways, and the lines denoting the mean and ± 3 standard deviations  are extended.  This construction forms the basis of the Control chart.   Time series data plotted on this chart can be compared to the lines,  which now become control limits for the process.  Comparing the plot  points to the control limits allows a simple probability assessment.  We  know from our previous discussion that a point plotted above the upper  control limit has a very low probability of coming from the same  population that was used to construct the chart - this indicates that  there is a Special Cause - a source of variation beyond the normal  chance variation of the process. | 
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  | Deploying Statistical Process Control is a process  in itself, requiring organizational commitment across functional  boundaries.  The flow-chart below outlines the major components of an  effective SPC effort.  The process steps are numbered for reference. | 
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  | Statistical Process Control is based on the  analysis of data, so the first step is to decide what data to collect.   There are two categories of control chart distinguished by the type of  data used:  Variable or Attribute.  Variable data comes from  measurements on a continuous scale, such as:  temperature, time,  distance, weight.  Attribute data is based on upon discrete distinctions  such as good/bad,  percentage defective, or number defective per  hundred. | 
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| MoreSteam  Hint: Use variable data whenever possible because it imparts a higher  quality of information - it does not rely on sometimes arbitrary  distinctions between good and bad. |  | 
   
  | A critical but often overlooked step in the  process is to qualify the measurement system.  No measurement system is  without measurement error.  If that error exceeds an acceptable level,  the data cannot be acted upon reliably.  For example: a Midwest building  products manufacturer found that many important measurements of its  most critical processes had error in excess of 200% of the process  tolerance.  Using this erroneous data, the process was often adjusted in  the wrong direction - adding to instability rather than reducing  variability.  See the Measurement Systems Analysis section of the Toolbox for additional help with this subject. | 
   
  | Develop a sampling plan to collect data  (subgroups) in a random fashion at a determined frequency.  Be sure to  train the data collectors in proper measurement and charting techniques.   Establish subgroups following a rational subgrouping strategy so that  process variation is captured BETWEEN subgroups rather than WITHIN  subgroups.  If process variation (e.g. from two different shifts) is  captured within one subgroup, the resulting control limits will be  wider, and the chart will be insensitive to process shifts. 
 The type of chart used will be dependent upon the type of data collected  as well as the subgroup size, as shown by the table below.  A bar, or  line, above a letter denotes the average value for that subgroup.   Likewise, a double bar denotes an average of averages.
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  | Consider the example of two subgroups, each with 5  observations.  The first subgroup's values are: 3,4,5,4,4 - yielding a  subgroup average of 4 (X̅1).  The second subgroup has the following values:  5,4,5,6,5 - yielding an average of 5 (X̅2).  The average of the two subgroup averages is (4 + 5)/2 = 4.5, which is called X double-bar (  ), because it is the average of the averages. | 
  | You can see examples of charts in Section 9 on Control Limits. | 
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  | Each process charted should have a defined  reaction plan to guide the actions to those using the chart in the event  of an out-of-control or out-of-specification condition.  Read Section 9  below to understand how to detect out-of-control conditions. One simple  way to express the reaction plan is to create a flow chart with a  reference number, and reference the flow chart on the SPC chart.  Many  reaction plans will be similar, or even identical for various processes.    Following is an example of a reaction plan flow chart: | 
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| MoreSteam  Note:  Specifications should NEVER be expressed as lines on control  charts because the plot point is an average, not an individual.  The  only exception is the moving range chart, which is based on a subgroup  size of one.  Consider the case of a subgroup of three data points:  13,  15, 17.  Suppose the upper specification limit is 16.  The average of  the subgroup is only 15, so the plot point looks like it is within the  specification, even though one of the measurements was out of spec.!   However, specifications should be printed on the side, top, or bottom of  the chart for comparing individual readings. |  | 
   
  | A control plan should be maintained that contains all pertinent information on each chart that is maintained, including: | 
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  |  | Chart Type |    |  | Chart Champion - Person(s) responsible to collect and chart the data |    |  | Chart Location |    |  | Measurement Method |    |  | Measurement System Analysis (Acceptable Error?) |    |  | Reaction Plan |    |  | Gauge Number - Tied in with calibration program |    |  | Sampling Plan |    |  | Process Stability Status |    |  | Cp & Cpk |  | 
  | The control plan can be modified to fit local needs.  A template can be accessed through the Control Plan section of the Toolbox. | 
   
  | Terms used in the various control chart formulas are summarized by the table below: | 
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  | Formulas are shown below for Attribute and Variable data.
 
 
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  |   (Here n = subgroup or sample size and k = number of subgroups or samples)
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  | Values for formula constants are provided by the following charts:
 
 
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 |  |   | Subgroup Size (n)
 | A2 | D3 | D4 | d2 |   | 2 | 1.880 | 0 | 3.267 | 1.128 |   | 3 | 1.023 | 0 | 2.574 | 1.693 |   | 4 | 0.729 | 0 | 2.282 | 2.059 |   | 5 | 0.577 | 0 | 2.114 | 2.326 |   | 6 | 0.483 | 0 | 2.004 | 2.534 |   | 7 | 0.419 | 0.076 | 1.924 | 2.704 |   | 8 | 0.373 | 0.136 | 1.864 | 2.847 |   | 9 | 0.337 | 0.184 | 1.816 | 2.970 |   | 10 | 0.308 | 0.223 | 1.777 | 3.078 |  | 
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 |  |   | Subgroup Size (n)
 | A2 | B3 | B4 |   | 11 | 0.927 | 0.322 | 1.678 |   | 12 | 0.886 | 0.354 | 1.646 |   | 13 | 0.850 | 0.382 | 1.619 |   | 14 | 0.817 | 0.407 | 1.593 |   | 15 | 0.789 | 0.428 | 1.572 |  | 
  | Chart examples:
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  | The area circled denotes an out-of-control condition, which is discussed below. | 
  | For more specific help in constructing SPC charts, see the MoreSteam Online SPC Course offering. | 
   
  | After establishing control limits, the next step  is to assess whether or not the process is in control (statistically  stable over time).  This determination is made by observing the plot  point patterns and applying six simple rules to identify an  out-of-control condition. | 
  | Out of Control Conditions: | 
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  |  | A. | If one or more points falls outside of the upper  control limit (UCL), or lower control limit (LCL).  The UCL and LCL are  three standard deviations on either side of the mean  - see section A of  the illustration below. |    | B. | If two out of three successive points fall in the  area that is beyond two standard deviations from the mean, either above  or below - see section B of the illustration below. |    | C. | If four out of five successive points fall in the  area that is beyond one standard deviation from the mean, either above  or below - see section C of the illustration below. |    | D. | If there is a run of six or more points that are  all either successively higher or successively lower - see section D of  the illustration below. |    | E. | If eight or more points fall on either side of the  mean (some organization use 7 points, some 9) - see section E of the  illustration below. |    | F. | If 15 points in a row fall within the area on  either side of the mean that is one standard deviation from the mean -  see section F of the illustration below. |  | 
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  | When an out-of-control condition occurs, the points should be circled on the chart, and the reaction plan should be followed. | 
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  | When corrective action is successful, make a note on the chart to explain what happened. | 
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| MoreSteam  Hint:  Control charts offer a powerful medium for communication.   Process shifts, out-of-control conditions, and corrective actions should  be noted on the chart to help connect cause and effect in the minds of  all who use the chart.  The best charts are often the most cluttered  with notes! |  | 
   
  | If an out-of-control condition is noted, the next  step is to collect and analyze data to identify the root cause.  Several  tools are available through the MoreSteam.com Toolbox function to  assist this effort - see the Toolbox Home Page.  You can use MoreSteam.com's Traction® to manage projects using the Six Sigma DMAIC and DFSS processes. | 
  | Remember to review old control charts for the  process if they exist - there may be notes from earlier incidents that  will illuminate the current condition. | 
   
  | After identifying the root cause, you will want to  design and implement actions to eliminate special causes and improve  the stability of the process.  You can use the Corrective Action Matrix to help organize and track the actions by identifying responsibilities and target dates. | 
   
  | The ability of a process to meet specifications  (customer expectations) is defined as Process Capability, which is  measured by indexes that compare the spread (variability) and centering  of the process to the upper and lower specifications.  The difference  between the upper and lower specification is know as the tolerance. | 
  | After establishing stability - a process in  control - the process can be compared to the tolerance to see how much  of the process falls inside or outside of the specifications.   Note:  this analysis requires that the process be normally distributed.   Distributions with other shapes are beyond the scope of this material. | 
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| MoreSteam  Reminder: Specifications are not related to control limits - they are  completely separate.  Specifications reflect "what the customer wants",  while control limits tell us "what the process can deliver". |  | 
  | The first step is to compare the natural six-sigma spread of the process to the tolerance.  This index is known as Cp. | 
  | Here is the information you will need to calculate the Cp and Cpk: | 
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  |  | Process average, or   |    |  | Upper Specification Limit (USL) and Lower Specification Limit (LSL). |    |  | The Process Standard Deviation (  ).  This can be calculated directly from the individual data, or can be estimated by:  |  | 
  | Cp is calculated as follows: 
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  | Following is an illustration of the Cp concept: | 
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  | Cp is often referred to as "Process Potential"  because it describes how capable the process could be if it were  centered precisely between the specifications.  A process can have a Cp  in excess of one but still fail to consistently meet customer  expectations, as shown by the illustration below: | 
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  | The measurement that assesses process centering in  addition to spread, or variability, is Cpk.   Think of Cpk as a Cp  calculation that is handicapped by considering only the half of the  distribution that is closest to the specification.  Cpk is calculated as  follows: | 
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  | The illustrations below provide graphic examples of Cp and Cpk calculations using hypothetical data: | 
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  | The Lower Specification Limit is 48 The Nominal, or Target Specification is 55
 The Upper Specification Limit is 60
 Therefore, the Tolerance is 60 - 48, or 12
 As seen in the illustration, the 6-Sigma process spread is 9.
 Therefore, the Cp is 12/9 or 1.33.
 
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  | The next step is to calculate the Cpk index: | 
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  | Cpk is the minimum of: 57-48/4.5 =  2, and  60-57/4.5  =  0.67 | 
  | So Cpk is 0.67, indicating that a small percentage of the process output is defective (about 2.3%). | 
  | Without reducing variability, the Cpk could be  improved to a maximum1.33, the Cp value, by centering the process.   Further improvements beyond that level will require actions to reduce  process variability. | 
   
  | The last step in the process is to continue to monitor the process and move on to the next highest priority. |  |  |  | 
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| Source --> http://www.moresteam.com/toolbox/t402.cfm | MoreSteam  Hint:  Statistical Process Control requires support from the top, like  any program.   The process will be most effective if senior managers  make it part of their daily routine to review charts and make comments.   Some practitioners initial charts when they review them to provide  visual support.  Charts that are posted on the floor make the best  working tools - they are visible to operators, and are accessible to  problem-solving teams. |  | 
 
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