STATISTICAL PROCESS CONTROL (SPC) REFERENCE MANUAL Second Edition, Issued July 2005 Issued 1992, Second Printing March 1995 (new cover only) Copyright © 1992, © 1995, © 2005 DaimlerChrysler Corporation, Ford Motor Company, and General Motors Corporation ISBN # 978-1-60534-108-8STATISTICAL PROCESS CONTROL SPC FOREWORD to Second Edition ‘This Reference Manual was developed by the Statistical Process Control (SPC) Work Group, sanctioned by the DaimlerChryslet/Ford/General Motors Supplier Quality Requirements Task Force, and under the auspices of the American Society for Quality (ASQ) and the Automotive Industry Action Group (AIAG). The Work Group responsible for this Second edition was prepared by the quality and supplier assessment staffs at DaimlerChrysler Corporation, Delphi Corporation, Ford Motor Company, General Motors Corporation, Omnex, Inc. and Robert Bosch Corporation working in collaboration with the Automotive Industry Action Group (AIAG). The Task Force charter is to standardize the reference manuals, reporting formats and technical nomenclature used by DaimlerChrysler, Ford and General Motors in their respective supplier assessment systems. Accordingly, this Reference Manual can be used by sny supplier to develop information responding to the requirements of either DaimlerChryster’s, Ford's or General Motors’ supplier assessment systems. This second edition was prepared to recognize the needs and changes within the automotive industry in SPC techniques that have evolved since the original manual was published in 1991. ‘The manual is an introduction to statistical process control. It iy not intended to limit evolution of SPC methods suited to particular processes or commodities. While these guidelines are intended to cover normally occurring SPC system situations, there will be questions that arise. These questions should be cirected to your customer's Supplier Quality Assurance (SQA) activity. If you are uncertain as to how to contact the appropriate SQA activity, the buyer in your customer's purchasing office can help. The Task Force gratefully acknowledges: the leadership and commitment of Vice Presidents Peter Rosenfeld at DaimlerChrysler Corporation, Thomas K. Brown at Ford Motor Company and Bo Andersson of General Motors Corporation; the assistance of the AIAG in the development, production and distribution of the manual; the guidance of the Task Force principals Hank Gryn (DaimlerChrysler Corporation), Russ Hopkins (Ford Motor Company), and Joe Bransky (General Motors Corporation). ‘Therefore this manual was developed to meet the specific needs of the automotive industry. This Manual is copyrighted by DaimlerChrysler Corporation, Ford Motor Company, aud General Motors Corporation, all rights reserved, 2005. Additional manuals can be ordered from ATAG andlor permission to copy portions of this manual for use within supplier organizations may be obtained from AIAG at 248- 358-3570 or httpu/www.aiag.org.ACKNOWLEDGEMENTS wo Second Edition The joint consensus on the contents of this document was effected through Task Team Subcommitice ‘Members representing DaimlerChrysler, Ford, and General Motors, respectively, whose approval signatures appear below, and who gratefully acknowledge the significant contribution of Gregory Gruska of Omnex Inc., Gary A. Hiner of Delphi Corporation, and David W. Stamps of The Robert Bosch Comp. The latest improvements were updating the format to conform to the current AIAG/ ISO/ TS 16249:2002 documentation, more clarification and examples to make the manual more user friendly and additional areas which where not included or did not exist when the original manual was written, The current re-write subcommittee is chaired by Mike Down from General Motors Corporation and consists of Todd Kerkstra and Dave Benham from DaimlerChrysler Corporation, Peter Cvetkovski from Ford Motor Company, Gregory Gruska, as 2 representative of the Omnex Inc. and ASQ, Gary A. Hiner of Delphi Corporation, and David W. Stamps of The Robert Bosch Corp. Michael H. Down Todd Kerkstra General Motors Corporation DaimlerChrysler Corporation Peter Cvetkovski David R. Benham Ford Motor Company DaimlerChrysler CorporationSTATISTICAL PROCESS CONTROL SPC FOREWORD to First Edition This Reference Manual was prepared by the quality and supplier assessment staffs at Chrysler, Ford and General Motors, working under the auspices of the Automotive Division of the American Society for Quality Control Supplier Quality Requirements Task Force, in collaboration with the Automotive Industry Action Group. The ASQC/AIAG Task Force charter is to standardize the reference manuals, reporting formats and technical nomenclature used by Chrysler, Ford and General Motors in their respective supplier assessment sysiems: Supplier Quality Assurance, Total Quality Excellence and Targets for Excellence. Accordingly, this Reference Manual can be used by any supplier to develop information responding to the requirements of either Chrysler's, Ford’s or General Motors’ supplier assessment systems. Until now, there has been no unified formal approach in the automotive industry on statistical process control, Certain manufacturers provided methods for their suppliers, while others had no specific requirements. In an effort to simplify and minimize variation in supplier quality requirements, Chrysler, Ford, and General Motors agreed to develop and, throug AIAG, distribute this manual. The work team responsible for the Manual’s content was led by Leonard A. Brown of General Motors. The manual should be considered an introduction to statistical process control. It is not intended to limit evolution of statistical methods suited to particular processes or commodities nor is it intended to be comprehensive of all SPC techniques. Questions on the use of alternate methods should be referred to your customer’s quality activity. ‘The Task Force gratefully acknowledges: the senior leadership and commitment of Vice Presidents Thomas T. Stallkamp at Chrysler, Clinton D. Lauer at Ford, and Donald A. Pais at General Motors; the technical competence and hard work of their quality and supplier assessment teams; and the invaluable contributions of the Automotive Industry Action Group (under AIAG Executive Director Joseph R. Phelan) in the development, production and distribution of this Reference manual. We also wish to thank the ASQC reading team led by Tripp Martin of Peterson Spring, who reviewed the Manual and in the process made valuable contributions fo intent and content. Bruce W. Pince Task Force Coordinator Sandy Corporation Troy, Michigan December, 1991 This Manual is copyrighted by Chrysler Corporation, Ford Motor Company, General Motors Corporation, all rights reserved, 1991. Additional copies can be ordered ftom A.L.A.G., and/or petmission to copy portions of the Manual for use within supplier organizations may be obtained from A.1.A.G. at (248) 358-3570,ACKNOWLEDGEMENTS to First Edition The joint consensus on the contents of this document was effected through Task Team Subcommittee Members representing General Motors, Ford, and Chrysler, respectively, whose approval signatures appear below, and who gratefully acknowledge the significant contribution of Pete Jessup of the Ford Motor Company, who was responsible for developing the majority of the material found in Chapters I, Il, and I, and the Appendix of this document. Harvey Goltzer of the Chrysler Corporation contributed concepts relative to process capability and capability studies, found in the introduction section of Chapter 1. Jack Herman of Du Pont contributed some of the concepts relative to capability and performance indices and the importance of measurement variability, found in portions of Chapters TI and IV, respectively. The General Motors Powertrain Division contributed the discussion and examples relative to subgrouping and process over-adjustment. The section in Chapter IT which provides understanding of process capability and related issues was developed by the General Motors Corporate Statistical Review Committee. This committee also contributed to the development of Chapter IV, Process Measurement Systems Analysis, s well as to some Appendix items. Finally, valuable input to sll sections of the manual was provided by ASQC representatives Gregory Gruska, Doug Berg, and Tripp Martin Leonard A. Brown, Victor W. Lowe, Jr David R. Benham, GM. Ford ChryslerVariables Control Charts. : ‘Average and Range Chars (, R) ‘Average and Standard Deviation Charts (%, ‘i 5) 83 Median and Range Charts (X, 3 R) 85 87 Individuals and Moving Range Charts (XY, MR) . Attributes Control Charts wn Control Charts for Nonconfarmiag Items . Proportion Nonconforming (p Chart)... ‘Number of Nonconforming Chart (np Chart) ‘Number of Nonconformities per Unit Chart (x Char ‘Number of Nonconformities Chart (¢ Chart). CHAPTER III ‘Other Types of Control Charts. Introduction Probability Based Chart ‘Short-Run Control Charts. Charts for Detecting Small Changes é Non-Normal Charts Multivariate. Other Chart Regression Control Charts. Residual Charts... Understanding Process Capability. and Process Performance for Variables Data... Introduction s A CHAPTERIY - Section A.. Definitions of Process Terms Process Measures for Predictable Processes . Indices — Bilateral Tolerances Indices ~ Unilateral Tolerances CHAPTER IV - Section B....snm Description of Conditions Handling Non-Normal and Multivariate Distributions .. Relationship of Indices and Proportion Nonconforming. Non-Normal Distributions Using Transformations... ‘Non-Normal Distributions Using Non-Normal Forms. Multivariate Distributions S CHAPTER IV - Seetion C. Suggested Use of Process The Loss Function Concep .. “Aligrinent of Process to Customer Requirements. APPENDIX A...... Some Comments on Sampling Effects of Subgrouping.Autocorrelated Data Multiple Stream Process Example. Effects of Sample Size on Indices. APPENDIX B. Some Comments on Sp Over-Adjustment... Time Dependent Processes. Repeating Patterns. APPENDIX C... Selection Procedure for the Use of the Control Charts Described in This Manual APPENDIX D verne Relationship Between Cy», and Other Indices APPENDIX E..... Table of Constants and Formulas for Control Charts. APPENDIX F Capability Index Calculations Example Data Set: : Analysis Diameter Statistis. Conctusion:. APPENDIX 6... Glossary of Terms and Symbols Terms Used in This Manual. Symbols as Used in This Manual. APPENDIX H... References and Suggested Readings APPENDIX I Standard Normal Table INDEX rrerwnr S.P.C. Manual User Feedback Process . xi .LIST OF ILLUSTRATIONS Figure 1.1: A Process Control System... Figure 12: Variation: Comman Cause and Special Cause.. Bs i Figure 1.3: Process Control and Process Capabilit ey 18 Figure 1.4: The Process Improvement Cycle .. Figure 1.5: Control Charts... Figure IL1: Variables Data Figure I1.2: Attributes Data Figure IL3: Elements of Control Charts. Figure I.4a: Sample Control Chart (Front side). Figure I14b: Semple Control Chart (back side) ~ Event Log Figure I1.5: Extending Control Limits . Figure [I.6: Control Limits Recalculation... Figure IL7: Extend Control Limits for Ongoing Control. Figure IL8: Process Variation Relative to Specification Limit Figure IL9: Points Beyond Control Limits ae Figure I1.10: Runs in an Average Contiol Chart. Figure IL.11: Runs in a Range Control Chart. Figure II. 12: Nonrandom Patterns in a Control Figure II.13: Average and Range Charts ... a IL14: Average and Standard Deviation Charts. Figure IL 15: Median and Range Charts. Figure 11.16: Individual and Moving Range Figure IL.17: Proportion Nonconforming Chart. Figure 11.18: Number of Nonconforming Chart. Figure II,19: Number of Nonconforming per Unit Chart Figure 11.20: Number of Nonconformities Chart Figure IIL 1: Control Charts Figure IIL.2: Stoplight Control. Figure IIL4: DNOM Cont Figure 11.5: CUSUM Chart with V-Mask. Figure II1.6: X, MR Chatt.. Figure II7: EWMA Chart of Viscosity . Figure IIL8: X, MR Chart of Viscosity. Figure IV.1: Within- and Between-Subgroup Variation Figure IV 2: Cpyand P,x Comparison. Figure IV.3: Comparison between a Predictable and Immature Process. Figure IV.4: Cpk and Ppk Values Produced by a Predictable and Immature Process Figure 1V.5: “Goal Post” vs. Loss Funetion gure IV 6: Comparison of Loss Function and Specifications. Figure 1V.7: Comparison of Loss Funetions. Figure IV.8: A Process Control System... Figure IV.9: Process Alignment to Requirements . xiiCHAPTER | Continual Improvement and Statistical Process Control‘This page intentionally left blank tT] qi |Introduction CHAPTER | Continual improvement and Statistical Process Control ‘To prosper in today’s economic climate, we — automotive manufacturers, suppliers and dealer organizations — must be dedicated to continual improvement. We must constantly seck more efficient ways to produce products and services. These products and services must continue to improve in value. We must focus upon our customers, both internal and ‘external, and make customer satisfaction a primary business goal. To accomplish this, everyone in our organizations must be committed to improvement and to the use of effective methods. This manual describes several basic statistical methods that can be used to make our efforts at improvement more effective. Different levels of understanding are needed to perform different tasks. This manual is aimed at practitioners and managers beginning the application of statistical methods. It will also serve as a refresher on these basic methods for those who are now using more advanced techniques. Not all basic methods are included here. Coverage of other basic methods (such as check sheets, flowcharts, Pareto charts, cause and effect diagrams) and some advanced methods (such as other control charts, designed experiments, quality function deployment, etc.) is available in books and booklets such as those referenced in Appendix H. ‘The basic statistical methods addressed in this manual include those associated with statistical process control and process capability analysis, Chapter I provides background for process control, explains several important concepts such as special and common causes of variation. Ii also introduces the control chart, which can be a very effective tool for analyzing and monitoring processes. Chapter I describes the construction and use of contro! charts for both variables' data and attributes data. Chapter II describes other types of control charts that can be used for specialized situations ~ probability based charts, short-run charts, charts for detecting small changes, non-normal, multivariate and other charts. Chapter IV addresses process capability analysis. The Appendices address sampling, over-adjustment, a process for selecting control charts, table of constants and formulae, the normal table, a glossary of terms and symbols, and references. ‘The term “Variables”, although awkward sounding, is used in order to distinguish the difference between something that varies, and the control chart used for data taken from a continuous variable.CHAPTER I ‘Continual improvement and Statistieal Process Control Six Points ee ae Six points should be made before the main discussion begins: a 2) 3) 4) 5) 6) Gathering data and using statistical methods to interpret them are not ends in themselves. The overall aim should be increased understanding of the reader's processes. It is very easy to become technique experts without realizing any improvements. Increased knowledge should become a basis for action. Measurement systems are critical to proper data analysis and they should be well understood before Process data are collected. When ‘such systems lack statistical control or their variation accounts for a substantial portion of the total variation in process data, inappropriate decisions may be made, For the purposes of this ‘manual, it will be assumed that this system is under control and is nota significant contributor to total variation in the data. The reader is referred to the Measurement Systems Analysis (MSA) Manual available from ALAG for more information on this topic. ‘The basic concept of studying variation and using statistieal signals to improve performance can be applied to any area. Such areas can be on the shop floor or in the office. Some examples are machines (performance characteristics), bookkeeping (error rates), gross sales, waste analysis (scrap rates), computer systems (performance characteristics) and materials management (transit times). This mamual focuses upon shop floor applications. The reader is encouraged to consult the references in Appendix H for administrative and service applications. SPC stands for Statistical Process Control. Historically, statistical methods have been routinely applied to parts, rather than processes. Application of statistical techniques to control output (such as parts) should be only the first step. Until the processes that generale the output become the focus of our efforts, the full power of these methods to improve quality, increase productivity and reduce cost may not be fully realized. Although each point in the text is illustrated with 2 worked-out example, real understanding of the subject involves deeper contact with process control situations. ‘The study of actual cases from the reader's own job location or trom similar activities would be an important supplement to the text. There is no substitute for hands-on experience This manual should be considered a first step toward the use of statistical methods. It provides generally accepted approaches, which work in many instances. However, there exist exceptions where it is improper to blindly use these approaches. This manual does not replace the need for practitioners to increase their knowledge of statistical methods and theory. Readers are encouraged to pursue formal statistical education. Where the reader's processes and application of statistical methods haveCHAPTER 1 Continual Improvement ang Statistical Process Contro} advanced beyond the material covered here, the reader is also encouraged to consult with persons who have the proper knowledge and practice in statistical theory as to the appropriateness of other techniques. In any event, the procedures used must satisly the customer's requirements.| E | ER | ~ Section A a THE NEED FOR PROCESS CONTROL Detection — Tolerates Waste Prevention — Avoids Waste i qCHAPTER |- Section A Prevention Versus Detection CHAPTER | —- Section A Prevention Versus Detection In the past, Manufacturing often depended on Production to make the product and on Quality Control to inspect the final product and screen out items not meeting specifications. In administrative situations, work is ofien checked and rechecked in efforts to catch errors. Both cases involve a strategy of detection, which is wasteful, because it allows time and materials 10 be invested in products or services that are not always usable. It is much more effective to avoid waste by not producing unusable ‘output in the first place — a strategy of prevention. ‘A prevention strategy sounds sensible ~ even obvious ~ to most people. It is easily captured in such slogans as, “Do it right the first time”. However, slogans are not enough. What is required is an understanding of the elements of a statistical process control system. ‘The remaining seven subsections of this introduction cover these clements and can be viewed as answers to the following questions: ‘© What is meant by a process control system? ‘* How does variation affect process output? + How can statistical techniques tell whether a problem is local in nature or involves broader systems? ‘¢ What is meant by a process being in statistical control? ‘What is meant by 2 process being capable? ‘+ What is a continual improvement cycle, and what part can process contro! play in it? «What are control charts, and how are they used? ‘+ What benefits can be expected from using control charts? As this material is being studied, the reader may wish to refer to the Glossary in Appendix G for brief definitions of key terms and symbols.ala MrT ns, PROCESS CONTROL SYSTEM MODEL WITH FEEDBACK VOICE OF THE PROCESS STATISTICAL METHODS PEOPLED EQuipmentp THE WAY mareriat/| WE WORK/ ome CUSTOMERS MeTHoDsP/ — BLENDING OF SERVICES MEASUREMENT) RESOURCES ENVIRONMENT. IDENTIFYING a a~ a CHANGING NEEDS INPUTS PROCESS/SYSTEM ourPuTs AND EXPECTATIONS VOICE OF THE CUSTOMER Figure |.1: A Process Control SystemCHAPTER T- Section B A Process Control Sysicm CHAPTER | - Section B A Process Control System A process control system can be described as a feedback system. SPC is one type of feedback system. Other such systems, which are not statistical, also exist. Four elements of that system are important to the discussions that will follow: 1. The Process ~ By the process, we mean the whole combination of suppliers, producers, people, equipment, input materials, methods, and environment that work together to produce output, and the customers Who use that output (see Figure 1.1). The total performance of the process depends upon communication between supplier and customer, the way the process is designed and implemented, and on the way it is operated and managed. The rest of the process control system is useful only if it contributes either to maintaining a level of excellence or to improving the total performance of the process 2, Information About Performance — Much information about the actual performance of the process can be learned by studying the process output. The most helpful information about the performance of a process comes, however, from understanding the process itself and its internal variability. Process characteristics (such as temperatures, cycle times, feed raies, absenteeism, tumover, tardiness, or number of interruptions) should be the ultimate focus of our efforts. We nced to determine the target values for those characteristics that result in the most productive operation of the process, and thea monitor how near to or far from those target values we are. If this information is gathered and interpreted correctly, it can show whether the process is acting in a usual or unusttal mannet. Proper ections can then be taken, if needed, to correct the process or the just-produced output. When action is needed it must be timely and appropriate, or the information-gathering effort is wasted. 3. Action on the Process — Action on the process is frequently most economical when taken to prevent the important characteristics (process ‘or output) from varying too far from their target values. This ensures the stability and the variation of the process output is maintained within acceptable limits, Such action might consist of: © Changes in the operations Y operator training ¥ changes to the incoming materials, © Changes in the more basic elements of the process itself Y the equipment ¥ how people communicate and relate Y- the design of the process as a whole ~ which may be vulnerable to changes in shop temperature or humidity ‘The effect of actions should be monitored, with further analysis and action taken if necessary.CHAPTER I - Section B A Process Conttl System 4, Action on the Output — Action on the output is frequently least economical when it is restricted to detecting and correcting out-of- specification product without addressing the underlying process problem. Unfortunately, if current output does not consistently meet customer requirements, it may be necessary to sort all products and to scrap or rework any nonconforming items. This must continue until the necessary corrective action on the process has been taken and verified. It is obvious that inspection followed by action on only the output is a poor substitute for effective process management. Action on only the output should be used strictly as an interim measure for unstable or incapable processes (sce Chapter I, Section E). Therefore, the discussions that follow focus on gathering process information and analyzing it so that action can be taken to correct the process itself. Remember, the focus should be on prevention not detection. 10 “4CHAPTER I~ Section B A Process Contol System This page intentionally left blank u :CHAPTER 1 Seotion © ‘Variation: Common and Special Causes PIECES VARY FROW EACH OTHER Aa fda H SS ae eS ee BUT THEY FORM A PATTERN THAT, IF STABLE, CAN BE DESCRIEED AS A DISTRIBUTION i. A ‘sZ@E——> DISTRIBUTION CAN DIFFER IN: Location ‘SPREAD snare ‘sze——> ‘se {F ONLY CoMNON CAUSES OF VARIATION ARE PRESENT, THE OUTPUT of A PROCESS. FORMS A DISTRIBUTION THAT IG STABLE OVER ‘TIME AND Is PREDICTABLE” ‘szE—> ee {F SPECIAL CAUSES OF VARIATION ARE PRESENT, THE PROCESS OUTPUT Is Nor STABLE GVER TIME. sas Figure 1.2: Variation: Common Cause and Special Cause 2CHAPTER 1— Section C ‘Variation: Commen and Special Causes CHAPTER | - Section C Variation: Common and Special Causes In order to effectively use process control measurement data, it is important to understand the concept of variation, as illustrated in Figure 12. ‘No two products or characteristics are exactly alike, because any process contains many sources of variability. The differences among products ‘may be large, or they may be immeasurably small, but they are always present. The diameter of a machined shaft, for instance, would be Susceptible to potential variation from the machine (clearances, bearing wear), tool (strength, rate of wear), material (diameter, hardness), operator (part feed, accuracy of centering), maintenance (lubrication, replacement of wom parts), environment (temperature, constancy of power supply) and measurement system. Another example is the time Tequired to process an invoice could vary according to the people performing various steps, the reliability of any equipment they were Using, the accuracy and legibility of the invoice itself, the procedures followed, and the volume of other work in the office. Some sources of variation in the process cause short-term, pieve-to-pioce differences, eg, backlash and clearances within a machine and its ffixturing, or the accuracy of a bookkeeper’s work. Other sources of variation tend to cause changes in the output only over a longer period of time, ‘These changes may oceur either gradually as with tool or machine ‘wear, stepwise as with procedural changes, or irregularly as with environmental changes such as power surges. Therefore, the time period ‘and conditions over which measurements arc made are critical since they will affect the amount of the total variation that will be observed. While individual measured values may all be different, as a group they tend to form a pattern that can be described as a distribution (see Figure 1.2). This distribution can be characterized by: ‘* Location (typical or “central” value) © Spread (span or “width” of values from smallest to largest) Shape (the pattern of variation — whether it is symmetrical, skewed, et) From the standpoint of minimum requirements, the issue of variation is often simplified: parts within specification tolerances are acceptable, - parts beyond specification tolerances are not acceptable; reports on time ¢ S- fre acceptable, late repor's are not acceptable. However, the goal should A be to maintain the location to a target value with minimal variability. To* ‘manage any process and reduce variation, the variation should be traced buck to its sources. The first step is to make the distinction between ‘common and special causes of variation, Common causes refer to the many sources of variation that consistently acting on the process. Common causes within a process produce a stable and repeatable distribution over time. This is called “in a state ofCHAPTER I - Section ‘Variation: Commen and Special Causes Statistical control,” “in statistical control,” or sometimes just “in control.” Common causes yield a stable system of chance causes. If only common causes of variation are present and do not change, the output of a process is predictable Special causes (often called essignable causes) refer to any factors causing variation that affect only some of tae process output ‘They are often intermittent and unpredictable. Speefal causes are signaled by one ex more points beyond the control limits or non-random patterns of Points within the control limits. Unless all the special causes of variation are identified and acted upon, they may continue to affect the process cutput in unpredictable ways. If special causes of variation are present, the process output will not be stable over time. ‘The changes in the process distribution due to special causes can be either detrimental or beneficial. When detrimental, they need to be understood and removed. When beneficial, they should be understood and made & permanent part of the process. With some mature processes’, the customer may give special allowance to run a process with a consistently occurring special cause. Such allowances will usually require that the process control plans can assure conformance to customer requirements and protect the process from other special causes (see Chapter I, Section E). * Processes that have undergone several cycles of continual improvement. 4 isCHAPTER I~ Section C ‘Variation; Commen and Special Couses This page intentionally left blank 15 ‘CHAPTER I~ Section D Local Actions And Actions On The System | LOCAL ACTIONS AND ACTIONS ON THE SYSTEM | Local Actions * Are usually required to eliminate special causes of variation * Can usually be taken by people close to the process * Can correct typically about 15% of process problems Actions on the System © Are usually required to reduce the variation due to common causes © Almost always require management action for correction | © Are needed to correct typically about 85% of process problems 16(CHAPTER [— Section D Local Actions Aad Actions On The System CHAPTER | - Section D Local Actions And Actions On The System > Dr. W. E. Deming has treated this issue in many artick 4 ‘There is an important connection between the two types of variation just discussed and the types of action necessary to reduce them.’ Simple statistical process control techniques can detect special causes of variation. Discovering a special cause of variation and taking the proper action is usually the responsibility of someone who is directly connected with the operation. Although management can sometimes be inyolved to correct the condition, the resolution of a special cause of variation usually requires local action, ic., by people directly connected with the operation. This is especially true during the early process improvement efforts. As one succeeds in taking the proper action on special causes, those that remain will often require management action, rather than local action. These same simple statistical techniques can also indicate the extent of common causes of variation, but the causes themselves need more detailed analysis to isolate. The correction of these common causes of ‘yariation is usually the responsibility of management. Sometimes people directly connected with the operation will be in a better position to identify them and pass them on to management for action. Overall, the resolution of common causcs of variation usually requires action on the system. Only a relatively small proportion of excessive process variation — industrial experience suggests about 15% — is correctable locally by people directly connected with the operation. The majority ~ the other 85% — is correctable only by management action on the system. Confusion about the type of action to take is very costly to the organization, in terms of wasted effort, delayed resolution of trouble, and aggravating problems. It may be wrong, for example, to take local action (eg, adjusting a machine) when management action on the system is required (eg, selecting suppliers that provide consistent input materials)’ Nevertheless, close teamwork between management and those persons directly connected with the operation is a must for enhancing reduction of common causes of process variation, e.g, see Deming (1967). ‘These observations were first made by Dr. J. M. Juran, and have been borne out in Dr. Deming’s experience.CHAPTER I~ Section E Process Control and Process Capability PROCESS CONTROL M.CONTROL (SPECIAL CAUSE ELIVINATED) OUT OF CONTROL (SPECIAL CAUSES PRESENT) PROCESS CAPABILITY IN CONTROL AND CAPABLE OF MEETING SPECIFICATIONS: (VARIATION FROM CONMON CAUSES HAS BEEN REDUCED) IW CONTROL BUT NOT CAPABLE (OF MEETING SPECFICATIONS (VARIATION FROM COMMON CAUSES IS EXCESSIVE) Figure 1.3: Process Control and Process Capability LToe CHAPTER | - Section E Process Control and Pracess Capability The process control system is an integral part of the overall business management system.’ As such, the goal of the process control system is to make predictions about the current and future state of the process, This Keads ( economically sound decisions about actions affecting the process. These decisions require balancing the risk of taking action when action is not necessary (over-control or “tampering") versus failing to take action when action is necessary (under-control).’ These risks should be handled, however, in the context of the two sourves of variation - special causes and common causes (see Figure |.3). A process is said to be operating in statistical control when the only sources of variation are common causes. One function of a process control system, then, is to provide a statistical signal when special causes of variation are present, and to avoid giving false signals when they are not present. This allows appropriate action(s) to be taken upon those special causes (either removing them or, if they are beneficial, making them permanent) The process control system can be used as a one-time evaluation tool but the real benefit of a process control system is realized when it is used as a continual learning tool instead of a conformance tool (good/bad, stable/not stable, capable/not capable, etc.) Control vs. Capability * See TS 16949, When discussing process capability, two somewhat contrasting concepis need to be considered: * Process capability + Process performance Process capability is determined by the variation that comes from common causes. It generally represents the best performance of the Process itself. This is demonstrated when the process is being operated in a state of statistical control regardless of the specifications Customers, intemal or extemal, are however more typically concerned with the process performance; that is, the overall output of the process and how it relates to their requirements (detined by specitications), irrespective of the process variation, “See W. E. Deming, (1994), and W. Shewhart, (1931), 19——————_—_—_—_——_—_—_——— (CHAPTER I Section & Process Control zad Process Capability In general, since a process in statistical control can be described by a predictable distribution, the proportion of in-specification parts can be @ estimated from this distribution. As long as the process remains in i statistical control and does not undergo a change in location, spread or shape, it will continue to produce the same distribution of in- specification parts. ‘Once the process is in statistical control the first action on the process should be to locate the process on the target. If the process spread is unacceptable, this strategy allows the minimum number of out-of- specification parts to be produced. Actions on the system to reduce the variation from common causes are usually required to improve the ability of the process (and its output) to meet specifications consistently. For a more detailed discussion of process capability, process performance and the associated assumptions, refer to Chapter IV. The process must first be brought into statistical control by detecting and acting upon special causes of variation. Then its performance Is predictable, and its capability to meet customer expectations can be assessed. This is a basis for continual improvement. Every process is subject to classification based on capability and control. A process can be classified into 1 of 4 cases, as illustrated by the following chart: Statistical Control @ { In-Control Out-of-Control Acceptable Case! Case 3 | | Capability ——_— —- | | Unacceptable Case 2 Case 4 To be acceptable, the process must be in a state of statistical control and the capability (common cause variation) must be less than the tolerance. ‘The ideal situation is to have a Case 1 process where the process is in statistical control and the ability to meet tolerance requirements is acceptable. A Case 2 process is in control but has excessive common cause variation, which must be reduced. A Case 3 process meets tolerance requirements but is not in statistical control; special causes of variation should be identified and acted upon. In Case 4, the process i not in control nor is it acceptable. Both common and special cause variation must be reduced. Under eectain circumstances, the customer may allow a producer to run a process cven though it is a Case 3 process. These circumstances may include: © The customer is insensitive to variation within specifications (see discussion on the loss function in Chapter IV). t i 20 :Process Indices CHAPTER I - Section B Process Control and Process Cepebility ‘+ The economics involved in acting upon the special cause exceed the benefit to any and all customers. Economically allowable special causes may include tool wear, tool regrind, cyclical (seasonal) variation, etc. ¢ The special cause has been identified and has been documented as consistent and predictable, In these situations, the customer may require the following: + The process is mature. '* The special cause to be allowed has been shown to act in a consistent manner over a known period of time. + A process control plan is in effect which will assure conformance to specification of all process output and protection from other special ‘causes or inconsistency in the allowed special cause. See also Appendix A fora discussion on time dependent processes. ‘The accepted practice in the automotive industry is to calculate the capability (common cause variation) only after a process has been demonstrated to be in a state of statistical control. These results are used as a basis for prediction of how the process will perform, There is little value in making predictions based on data collected from a process that is not stable and not repeatable over time. Special causes are responsible for changes in the shape, spread, or location of a process distribution, and thus can rapidly invalidate prediction about the process. That is, in ‘order for the various process indices and ratios to be used as predictive tools, the requirement is that the data used to calculate ‘them are gathered from processes that are in a state of statistical control, Process indices can be divided into two categories: those that are calculated using within-subgroup estimates of variation and those using total variation when estimating a given index (see also chapter IV), Several different indices have been developed because: 1) No single index can be universally applied to all processes, and 2) No given process can be completely described by a single index. For example, it is recommended that C, and Cx both be used (see ‘Chapter IV), and further that they be combined with graphical techniques to better understand the relationship between the estimated distribution and the specificatioa limits. In one sense, this amounts to comparing (and" trying to align) the “voice of the process” with the “voice of the customer” (see also Sherkenbach (1991)). All indices have weaknesses and can be misleading. Any inferences drawn from computed indices should be driven by appropriate interpretation of the data from which the indices were computed.ee CHAPTER I- Section E Process Control and Process Capability ‘the reader's responsibility to communicate with their customer and Getermine which indices to-use, In some cases, it might be best to use no ‘ndex at all. It is important to remember tbat most capability indices jnolude the product specification in the formula. If the specification is inappropriate, or not based upon customer requirements, much time and @ffon may be wasted in trying to force the process to conform. Chapter TY deals with selected capability and performance indices and contains advice on the application of those indices. ‘Automotive companies have set requirements for process capability. [tis @ aThis page intentionally left blank 23 (CHAPTER I Section E Process Control and Process CapabilityCHAPTER I~ Section F ‘The Process Improvement Cycle and Process Control STAGES OF THE CONTINUAL PROCESS IMPROVEMENT CYCLE 1. ANALYZE THE PROCESS 2. MAINTAIN THE PROCESS - Monitor process performance - What should the process be doing? What can go wrong? - Detect special causa - What is the process doing? variation and act upon it. -Achieve a state of statistical control. - Determine capability PLAN ‘stuby 3. IMPROVE THE PROCESS ~ Change the process to better STUDY ncetsand common cause variation - Reduce common cause variation. Figure 1.4: The Process Improvement Cycle :CHAPTER I - Section F ‘The Prosess Improvement Cyele and Process Control HAPTER I - Section F Tn applying the concept of continual improvement to processes, there is a three-stage cycle that can be useful (see Figure 14). Every process is in one of the three stages of the Improvement Cycle. 41. Analyze the Process A basic understanding of the process is a must when considering process improvement. Among the questions to be answered in order to achieve @ beiler understanding of the process are: What should the process be doing? What is expected at each step of the process? Y What are the operational definitions of the deliverables? © What can go wrong? ¥ What can vary in this process? ¥ What do we already know about this process’ variability? Y What parameters are most sensitive to variation? ‘© What is the process doing? Ys this process producing scrap or output that requires rework? Y Does this process produce output that is in a state of statistical control? Is the process capable? Is the process reliable? ‘Many techniques discussed in the APQP Manual” may be applied to gain a better understanding of the process. These activities include: * Group meetings * Consultation with people who develop or operate the process (subject matter experis”) «Review of the process’ history ‘© Construction of a Failure Modes and Effects Analysis (FMEA) Control charts explained in this manual are powerful tools that should be used during the Process Improvement Cycle. These simple statistical methods help differentiate between common and special causes of variation. The special causes of variation must be addressed. When a state of statistical control has been reached, the process’ current level of long-term capability can be assessed (see Chapter [V). ” Chrysler, Ford, and General Motors, (11995),charg RI Section F = “oss Inproveient Cycle and Process Control 2. Maintain (Control) the Process Once a better understanding of the process has been achieved, the Process must be maintained at an appropriate level of capability. Processes are dynamic and will change. The performance of the process Should be monitored so effective measures to prevent undesirable change gan be taken. Desirable change also should be understood and institutionalized, Again, the simple statistical methods explained ia this mamual can aésist, Construction and use of control charts and other tools Will allow for efficient monitoring of the process. When the tool signals that the process has changed, quick and efficient measures can be taken to isolate the cause(s) and act upon them, Itis too easy to stop at this stage of the Process Improvement Cycle. It is important to realize that there is a limit to any company’s resources. Some, pethaps many, processes should be at this stage. However, failure {0 proceed to the next siage in this cycle can result in a significant competitive disadvantage. The attainment of “world class” requires a steady and planned effort to move into the next stage of the Cycle 3. Improve the Process Up to this point, the effort has been to stabilize the processes and maintain them. However, for some processes, the customer will be Tetsilive even to variation within enginecring specifications (see Chapter IV), In these instances, the value of continual improvement will not be realized until variation is reduced. At this point, additional process analysis tools, including more advanced statistical methods such as Scsigned experiments and advanced control charts may be useful, Appendix H lists some helpful references for further study. Process improvement through variation reduction typically involves PivPescfully introducing changes into the process and measuring the etfects. The goal is a better understanding of the process, so that the common cause variation can be further reduced. ‘The intent of this reduction is improved quality at lower cost. When new process parameters have been determined, the Cycle shifts back to Analyze the Process. Since changes have been made, process stability will need to be reconfirmed. The process then continues to ‘move around the Process Improvement Cyele 26CHAPTER I—Section F Improvement Cyele and Process Control This page intentionally left blankCHAPTER I - Section G Control Charts: Tools For Process Control and Improvement Upper Control Limit Center Line Lower Control Limit 1. Collection * Gather Data and plot on a chart. 2. Control + Calculate trial control limits from process data. + Identify special causes of variation and act upon them. 3. Analysis and Improvement * Quantify common cause variation; take action to reduce it. These three phases are repeated for continual process improvement Figure 1.5: Control Charts(CHAPTER I - Seaion G ‘Coauol Chans: Tools For Process Control and Improvement HAPTER | - Section G Tools For Process Control and Improvement In his books", Dr. W. E. Deming identifies two mistakes frequently made in process control: “Mistake 1. Ascribe a variation or a mistake to a special cause, when in fact the cause belongs to the system (common causes), Mistake 2. Ascribe a variation or a mistake to a system (common causes), when in fact the cause was special. Over adjustment [tampering] is a common example of mistake No. 1. Never doing anything to try to find a special cause is a common example of mistake No.2." For effective variation management during production, there must be an effective means of detecting special causes. There is @ common misconception that histograms can be used for this purpose. Histograms are the graphical representation of the distributional form of the process variation, The distributional form is studied to verify that the process Variation is symmetric and unimodal and that it follows @ normal distribution. Unfortunately normality does not guarantee that there are no speciel causes acting on the process. That is, some special causes may change the process without destroying its symmetry or unimodality. Also a non normal distribution may have no special causes acting upon it but its distributional form is non-symmetric. Time-based statistical and probabilistic methods do provide necessary and sufficient methods of determining if special causes exist. Although several classes of methods are uscful in this task, the most versatile and robust is the genre of control charts which were first developed and implemented by Dr. Walter Shewhart of the Bell Laboratories’ while studying process data in the 1920's. He first made the distinction between controlled and uncontrolled variation -due to what is called ‘common and special causes. He developed a simple but powerful tool to separate the two — the control chart, Since that time, control charis have been used suecessfilly in a wide variety of process control and improvement situations. Experience has shown that control charts effectively direct attention toward special causes of variation when they oveur and reflect the extent of common cause variation that must be reduced by system or process improvement. It is impossible to reduce the above mistakes to zero. Dr. Shewhart realized this and developed a graphical approach to minimize, over the Jong run, the economic loss from both mistakes. * Deming (1989) and Deming (1994). ° Shewhart (1931).(CHAPTER I Section G Contol Chars: Tools For Process Consol and improvement If process control activites assure that no Special cause sources of Narlation are active, the process is said to be in statistical control or “in Sputrol.” Such processes are said to be stable, Predictable, and consistent Since it is possible to predict” the performance of the process, Zit active existence of any special cause will render the Process out of praustical control or “out of contol.” The performance of such unstable Processes cannot be predicted. Control Limits When Shewhart developed control charts he was concemed with the When eontTOl OF processes; i.c., action is taken on the Process only When special causes are present. To do this, sample statistics are compared to control limits. But how are these limits determined? Foasides a process distribution that can be described by the normal form, The goal is to determine when special causes are affecting it. Another way of saying this is, “Has the process changed sinew 4 Was last looked at itor during the period sampled?" Has the process Leen a Eiace the normal distribution is described by its Process location (mean) al Process width (range or standard deviation) vive uestion becomes: . Has the process location or process width changed? Consider only the location, What approach can be Used to determine if the process location has changed? One Possibility would be to look at eS eae = This is done by using the process information to identify and eliminate the existence of special causes or detecting them and removing their effect when they do occur. awrth all probabilistic methods some risk is imme, The exact level of belief in prediction of future actions cannot be determined by’ sutianee measures alone, Subject-matter expertise igCHAPTER I~ Section ‘Control Charts: Tools For Process Contrl and Improvement The ean Produced by the process, but that is usually not economical, Tite alternative is to vse a sample of the process, and calculate the mean of the sample. Has the process location changed take n samples) calculatex | If the provess has of changed, will the sample mean be equal 10 the distribution mean? {The answer is that this very rarely happens. But how is this possible? all, the process has not changed, Doesn't that imply that the process mean remains the same? The reason for this is that the sample mean is only an estimation of the process mean. To make this a little clearer, consider taking a sample of size one. The mean of the sample is the individual sample itself, With such random samples from the distribution, the readings will eventually cover te entire process range. Using the formula: Range of the distribution of means ( (jc) Poses Range vn for a sample of size four, the resulting range of sample averages will be yVt~ fof the process range; for a sample of size 100 it will be yii00 =, of the process range.” Shewhart used this sampling distribution to establish an operational definition of “in statistical control.” First, start off with the assumption that the process is in statistical control, ie. innocent until proven guilty Then, compare the sample t0 the sampling distribution using the 23 Sandard deviation limits". These are called control limits, If the sample falls outside these limits then there is reason to believe that special Sahib ent Further, itis expected that all the (random) samuples will Exhibit 2 random ordering within these limits. If a group of samples shows a patter there is reason to believe that a special cave to Present. (see Chapter I, Section C, and Chapter Il, Section A). "3 See the Central Limit Theorem. ° Shewhart selected the 43 standard Ceviation limits as useful limits in achieving the sconomic control of Processes, 31 4CHAPTER Conte! Cha take n samples: calculate Ler due to Sampling Variation In general, to set up a control chart we calculate: Centerline ~ average of the statistic being analyzed UCL = upper control limit = centerline + 3 x standard deviation of the av rages TCL = lower contro limit = centerline -3 x standard deviation of the averages Approac: ( Since Control Charts provide the operational definition of “in statistical Cuutoh” they are useful tools at every stage of the Improvement Cycle (Gee Chapter I, Section F). Within each stage, the PDSA” cycle shovid be used, For analysis of existing data sets For the Analysis and Improvement stages of the cyele + Review the data Ts the metric appropriate; Le., does it reflect a process attribute and tied to a key business factor? “Are the data consistent; ic., is the same operational definition « used by all parties collecting the data? “Ate the data reliable; ie., is a planned data collection scheme utilized? % Isthe measurement system appropriate and acceptable? * Plot the data: Y Plot using the time order “Compare to control Limits and determine if there are any points outside the control limits cacti d *Plan-Do-Study-Act cycle; also known as the PDCA, (Plan-Do-Che k-Act) cycle.CHAPTER I~ Section G (Control Charts: Tools For Process Control and Improvement Y Compare to the centerline and determine if there are any non- random pattems clearly discernible + Analyze the data © Take appropriate action The daia are compared with the control limits to see whether the variation is stable and appears to come from only common causes. If special causes of variation are evident, the process is studied to further determine what is affecting it. After actions (see Chapter I, Section D) have been taken, further daia are collected, control limits are recalculated if necessary, and any additional special causes are acted upon. ‘After all special causes have been addressed and the process is running in statistical control, the control chart continues as a monitoring tool. Process capability can also be calculated. If the variation fom common causes is excessive, the process cannot produce output that consistently meets customer requiremeats. The process itself must be investigated, and, typically, management action must be taken to improve the system. For control ‘© Review the data collection scheme before starting: ¥ Is the metric appropriate; i.e., does it reflect a process attribute and tied to a key business factor? Y Will the data be consistent; ie. is the same operational definition used by all parties collecting the data? Y Will the data be reliable; ic., is a planned data collection scheme used? Is the measurement system appropriate and acceptable? © Plot each point as it is determined: ¥ Compare to control limits and determine if there are any points, outside the control limits Y Compare to the centerline and determine if there are any non- random patterns clearly discernible © Analyze the data * Take appropriate ation: Continue to run with no action taken; or y Identify source of the special cause and remove (if unacceptable response) or reinforee (if acceptable response); or Y Continue to run with no action taken and reduce sample size or frequency; or ¥ Initiate a continval improvement action Ofen it is found that although the process was aimed at the target value during initial setup, the actual process location ( 42)’ may not ‘The Greek letter 41 is used to indicate the actual process mean, which is estimated by the sample mean X. 33CHAPTER | — Section G Control Charts: Tools Fer a roeess Control and Improvement eon, USSR ios: processes where the sctaal location Geviates from the target and the ability to relocate Ge process is 50 thal fi aheeeration should be given to adjusting uke process sett itis aligned with the target (sce Chapier IV, Soci ©). This fig may ot always hold true, but the causes ter any possible increase in process variation aft. Te-targeting the process should be understood and assessed against both customer satisfaction and economics, analyzed. This can be accomplished by 1 period con systematic review of the ongoing control charts” Now evidence of special ile wash be revealed. Some special causes, wher understood, Rall be beneficial and useful for process improvimees Others will be detrimental, and will need tobe eousected or Temoved. | The Purpose of the Improvement ‘Cycle is to gain an understanding of the | process and its variability to ‘improve Performance. As this understanding matures, the need ior continual monitoring of product variables may become less — especially in processes Where | Gocumented analysis shows inat the deminat source of variation are | more ‘ficiently and effectively controled oy can approaches. For | exemple: in Plocesses where maintenance is the dominant source of | vanation, the procose i no, controled by preventive and predictive | Maintenance; for Processes where process ‘setup is the dominant ‘source | of Variation, the process is best controlled by setup contro} charts. For a process focus on reducing the common cause varitin ne Process, Reducing this variation will have the effect of “shrinking” the control limits on the control chart (ie, the limits, upon their recalculation, will be closer tteether). Many people, not familiar with sonal charts, feel this is sPenalizing™ the process for improving They do not realize that if a Prcess is stable and the control limits are caleulse correctly, the recalculation of control limits. For long-term analysis of control charts, it is best to recalculate control limits ae infrequently as possible; only dictated by changes in the ‘Process, For continual process improvement, fepeat the three stages of the Improvement Cycle: Analyze the Process. Maintain (Control) the Process; Improve the Process, sec Figure 1d 34CHAPTER I ~ Section G Control Charts: Tools For Process Contrl end Improvement ‘This page intentionally left blank Eo(CHAPTER {~Scction H [Effective Use and Benefits Of Control Charts BENEFITS OF CONTROL CHARTS Properly used, control charts can: | * Be used by operators for ongoing control of a process | © Help the process perform consistently and predictably « Allow the process to achieve — Higher quality — Lower unit cost — Higher effective capability «Provide @ common language for discussing the performance of the process + Distinguish spacial from common causes of variation, as a guide to local action or action on the system. ¢CHAPTER | Seetion H Effective Use and Benefits Of Contiol Charts, CHAPTER | - Section H Effective Use and Benefits of Control Charts benefits can be obtained from the effective use of control ie gains and benefits from the control charts are directly related (o the following: Management Philosophy: How the company is managed can directly impact the effectiveness of SPC. The following are examples of what needs to be present © Focus the organization on variation reduction. © Establish an open environment that minimizes internal competition and supports cross-functional teamwork. © Support and fisnd management and employee training in the proper use and application of SPC. ‘+ Show support and interest in the application and resulting benefits of properly applied SPC. Make regular visits and asks questions in those areas © Apply SPC to promote the understanding of variation in en; processes, ering © Apply SPC to management data and use the information in day-to- day decision making. The above items support the requirements contained in ISO 9000:2000 and ISOITS 16949:2002. Engineering Philosophy: How engineering uses data to develop designs can and will have aa influence on the level and type of variation in the finished product. The following are some ways that engineering can show effective use of SPC: * Focus the engineering organization on variation reduction throughout the design process; e.g., mumber of design changes, design for manufacturing and assembly, personnel moves, etc Establish an open engineering environment that minimizes internal ‘competition and supports cross-functional teamwork. * Support and fund engineering management and employees taining im the proper use and application of SPC. + Apply SPC to promote the understanding of variation in engineering processes. © Require an understanding of variation and stability in relation 10 ‘measurement and the data that are used for design development. 7 :CHAPTER I - Section 11 Effective Use and Benefits Of Control Chars © Support engineering changes proposed due to analysis of SPC information lo aid in the reduction of variation. Manufacturing: How manufacturing develops and operates machines and transfer systems can impact the level and type of variation in the finished produc: © Focus the manufacturing organization on variation reduction; e.g., ‘number of éifferent processes, impact of multi-fixture and multi-too| processes, tool and machine maintenance, etc. ‘© Establish an open enginecring environment that minimizes internal competition and supports cross-functional teamwork, * Support and find manufacturing management and employees training in the proper use and application of SPC. + Apply SPC in the understanding of variation “n ihe manufacturing ‘processes. + Require an understanding of variation and stability in relation to measurement and the data that are used for process design development. «Use the analysis of SPC information to support process changes for the reduction of variation. + Do not release control charts to operators until the process is stable. ‘The transfer of responsibility for the process to production should cccur afer the process is stable. ‘+ Assure proper placement of SPC data for optimum use by the employees. Quality Control: The Quality function is a critical component in providing support for an effective SPC process: * Support SPC taining for management, engineering, and employees in the organization. * Mentor key people in the organization in the proper application of SPC. © Assist in the identification and reduction of the sources of variation. © Ensure optimum use of SPC data and information. Production: Production personnel are directly related to the provess and can affect process variation. They should: ‘© Be properly trained in the application of SPC and problem solving. , ‘+ Have an understanding of variation and stability in relation to ‘measurement and the data that are used for process control and improvement. * Be alert to and communicate when conditions change. * Update, maintain and display control charts within area of responsibilty. 0 ¢