FDFPPL4005A Establish Process Capability Contents Introduction and Unit Details ………….………………………………….... 4 Element 1: Prepare to Conduct a Capability Study……………………. 7 Preparation and Sampling………………….……………………………….... 8 Considerations for the Statistical Process Control Chart…………………. 9 Element 2: Analyse Data to Determine Process Capability..………… 17 Process Control Charts……………………………………………………….. 18 Process Capability…..………………………………………………………... 24 Analysis and Interpretation of the Control Chart..………………………….. 28 Capability Index……………………………………….…………………….... 34 Continuing Improvement ……………………………………………………. 40 Activity Answers……………………………………………………………. 41 Appendix 1……………………………………………………………………. 43 Appendix 2……………………………………………………………………. 47 © Food-Wise Training Solutions Version 1.1 Page of 46 FDFPPL4005A Establish Process Capability Element 1: Prepare to Conduct a Capability Study. Learning Objectives When you have finished this section you should be able to: Identify the purpose and scope of the process to be investigated Design a control chart which collects representative data of the defined process Page of 46 © Food-Wise Training Solutions Version 1.1 FDFPPL4005A Establish Process Capability Preparation and Sampling Control charts are widely used to establish and maintain statistical control of a process. They are also effective devices for estimating process parameters, particularly in processcapability studies. The use of a control chart requires the analyst to select a sample size, a sampling frequency or interval between samples and the control limits for the chart. The selection of these three parameters is usually called the design of the control chart. It is not always possible to give an exact solution to the problem of control chart design, as detailed information is needed on: Statistical characteristics of the control chart tests Economic factors that affect the problem A complete solution of the problem would require knowledge of the Cost of sampling and testing include the out-of-pocket expenses of inspectors and technicians' salaries and wages, the costs of any necessary test equipment and in the case of destructive testing the unit cost of the items sampled. 1 Cost associated with production of a product that does not meet specifications Models for the economic design of control charts can be calculated2 but this is beyond the scope of this unit of competency. Traditionally control charts have been designed with respect to statistical criteria only. This usually involves selecting the sample size and control limits such that the power to detect a particular shift in the quality characteristics and the probability of a ‘false alarm’ (type I error) are equal to specified values. Obviously you would not have this information if there has never been a statistical evaluation of the process. Control charts do not control the process, they are tools used to improve the process. Generally processes do not operate in a state of statistical control and consequently routine and attentive use of control charts will identify assignable causes. If these causes can be eliminated from the process, variability will be reduced and the process will be improved. The control chart will only detect assignable causes. Management, operator, and engineering action will be necessary to eliminate the assignable cause. 3 Two concepts which are fundamental in the control of quality are measurement and variation. Measurement of some kind is necessary in describing product quality (goods and services), whether on a continuous scale producing variable data or a number counting resulting in attribute data. After-all, what can’t be measured can’t be controlled and if it can’t be controlled , it can’t be improved. 1 (Montgomery, 1991, pp. 112-113) (Montgomery, 1991, pp. 413 - 443) 3 (Montgomery, 1991, p. 106) 2 © Food-Wise Training Solutions Version 1.1 Page of 46 FDFPPL4005A Establish Process Capability 3 δ either side of the mean contains 99.73% of the values The two tails contain the remainder of 2.7% or 0.0027 of the values (that is 100% - 99.73% = 2.7%) 370 is the average run length of the x-bar chart when the process is in control. That is, even if the process remains in control, an out-of-control signal will be generated every 370 samples on average. Consider the example used earlier of the opening diameter of a glass jar and suppose sampling occurred every hour. In this instance a false alarm would occur approximately every 370 hours. Page of 46 © Food-Wise Training Solutions Version 1.1 FDFPPL4005A Establish Process Capability 4 Taking the sample Samples need to be random and there be an equal chance of being selected. A representative sample contains the relevant characteristics of the population in the same proportion as they are included in that population. If one accepts that a main objective of keeping a control chart is to detect a sustained change in the process mean ,(that is, the average value of the characteristic being investigated), then samples, should be chosen ‘instantaneously’ so that each sample is as homogeneous as possible. In such a situation, the sample should consist of a number, say 5, of successively produced items to maximise the opportunity for variation between samples and increase the sensitivity of the chart to detect a disturbance. On the other hand, if the control chart is to be used to detect short-lived or compensating changes in the mean (that is, where the change may occur after one ‘instantaneous’ sample but be corrected before the next), then the sample should be chosen at random from all items produced over a suitable given time period so that it is representative of production over that time period. 4 To establish the inherent variation in the process, allow the process to run untouched (that is, according to procedures). Culturally, staff collecting the data must feel ‘safe’ to report data as they find it, even if it gives undesirable results otherwise the staff with their familiarity with the machinery will collect biased data. An example of this is with the hamburger patty assessment question. If only two samples were taken, the staff might know which two samples would give the desired weight (as the former may deposit heavy in the middle and lighter on the edges) 5 Create charts / sheets for data collection Sheets for the collection of data will need to be designed / created. They can be created to collect the raw data which is then later analysed or once having established control limits also used to monitor the process. The data collection forms should also include provision for recording any unusual events that occur (which would then be used to eliminate assignable causes). An example of such a sheet is on the following page and in Appendix 1. 4 (Ogle, 1994) © Food-Wise Training Solutions Version 1.1 Page of 46 FDFPPL4005A Establish Process Capability © Food-Wise Training Solutions Page of 46 Version 1.1 FDFPPL4005A Establish Process Capability Process Control Chart The process control chart has been covered in considerable detail in the pre-requisite units of competency FDFOP2015A Apply Principles of Statistical Process Control and FDFTEC4007A Describe and analyse data using mathematical principles. The histogram is related to the control chart. Like a histogram, a normally distributed control chart will have almost all its values with +/- 3 standard deviations from the mean. Below is a diagramatic representation of how variation (or the spread of the data), usually represented by the normal distribution curve, can be translated into a control chart. UL 3δ 3δ LL 3 δ either side of 𝒙 is a total of 6 δ © Food-Wise Training Solutions Version 1.1 Page of 46 FDFPPL4005A Establish Process Capability Rule 4 The proportion of points within the middle 1/3 of the region between the control limits differs excessively from 2 out of 3 Special Causes - Rule 4 2 out of 3 fall outside or inside the third (1δ) lines 18 16 14 12 10 8 6 4 2 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 Additional Criteria 1. Two of three consecutive points outside the 2-sigma warning limits but still inside the control limits Special Causes - 2 out of 3 points exceed warning limits 18 16 UNL (3δ) 14 UWL (2δ) 12 (1δ) 10 Value 8 Avg 6 (1δ) 4 LWL (2δ) 2 LNL (3δ) 0 1 Page of 46 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 © Food-Wise Training Solutions Version 1.1 FDFPPL4005A Establish Process Capability conforming if the process is not satisfactorily centered in respect to the specifications. Cp <1 This implies that specifications are not being met in which case three courses of action arise: o Change specifications. In some situations specifications may be set more tightly than necessary. It may be possible to make headway through negotiation o Reduce process variability. This may involve an analysis of the sources of variation in the process. In turn, this may lead to changes to particular aspects of the process, for example, method, materials or equipment used. A further capability study may be required. o Accept the status quo. Of course, this alternative is hardly a course of action. However, if such a situation is unavoidable (hopefully) in the shortterm, management must accept that some process outcomes will continue to fall short of what is required so that the economics of the operation become paramount. What is the percentage of non-conforming outcomes? Where should the process be centered in order to minimize scrap/rework costs? Cpk = 1 , both specifications are at least three standard deviations from the process centre. Such a process could be described as having 3δ (3-sigma) capability. Similarly, values of Cpk = 1.33, 1.67 and 2 would correspond to capabilities of 4δ , 5δ and 6δ respectively. Cpk < 1 defective material is being made Cpk, Cpl and Cpu measure not only the process variation with respect to the allowable specification, they also take into account the location of the process average. NOTE: The indices Cpl and Cpu can be used for single-sided specification limits If the process is not capable, form a team to identify and correct common causes of the variation in the process. Process capability, based on individual data for the process population is used to determine if a process is capable of meeting customer requirements or specifications. It represents a ‘snapshot’ of the process for some specific period of time. Control charts use small sample sizes over time and look at averages. The control limits are natural limits of variation of the averages within the sample. These limits are not be confused with specification limits, which are for individual data points in the population. Attribute Control Charts. The process capability of an Attribute Data Control chart is represented by the process averages p , n p , c and u . © Food-Wise Training Solutions Version 1.1 Page of 46 FDFPPL4005A Establish Process Capability Continuing Improvement Process control charts and process capability studies in themselves do not solve quality problems but as management tools they assist in focusing attention on the issues of quality and productivity improvement. Once the initial process control chart and capability analysis has been undertaken it is necessary to”: 1. Determine any special causes if the process is considered out of control. Special causes can include changes in raw materials or methods, damaged or worn equipment, faulty gauges or human errors, poor lighting, badly designed work stations, inadequate supervision and training. Some of the causes can be corrected ‘locally’ by appropriate personnel, others will require resolution by senior management. o Further statistical process control techniques (such as pareto, cause and effect diagrams etc) along with other general methods (such as quality circles, brainstorming) may also be employed to identify special causes, reduce variation and improve processes. 2. Once the special causes have been determined and eliminated, the control limits for a process control chart will need to be recalculated 3. Rectifying any special causes may have a flow on effect and also improve process capability. Modifications to equipment, the process or the design of the product can improve process capability; if this is not the case the following should be considered o Change specifications. In some situations specifications may be set more tightly than necessary. It may be possible to make headway through negotiation o Reduce process variability. This may involve an analysis of the sources of variation in the process. In turn, this may lead to changes to particular aspects of the process, for example, method, materials or equipment used. A further capability study may be required. o Accept the status quo. Of course, this alternative is hardly a course of action. However, if such a situation is unavoidable (hopefully) in the shortterm, management must accept that some process outcomes will continue to fall short of what is required so that the economics of the operation become paramount. What is the percentage of non-conforming outcomes? Where should the process be centered in order to minimize scrap/rework costs? 4. Sampling and analysis for process control should be ongoing and as special causes are gradually removed, benefits will be received comprising of greater profits, better quality and increased productivity. The reasons for such improvements include reductions in scrap and rework, preventative actions rather than remedial and a better understanding of process capability. Page of 46 © Food-Wise Training Solutions Version 1.1