Process Capability Technique

Because we re primarily concerned about innovation, we ll focus on its predictive use. For example, if you ve designed a new insulin pump, it should be capable of administering a certain amount of the hormone at a certain rate into the patient s body. If you determine that the pump s ability to consistently perform is lacking, you can use the Process Capability technique to improve its design by optimizing the settings of the pump s input variables (radius of the piston, motor speed, etc.). 

Build a scorecard for each critical process using data from capability studies (see Process Capability, Technique 37), past experience, manufacturing data, and estimates from similar processes. You can then use this data to predict the overall performance of each of the critical processes and subprocesses. 

Are there any design corrections that can be made to improve performance (See Robust Design, Technique 38, and Process Capability, Technique 37.)... 

Process capability is the ability of the process to meet or exceed the specification limits you ve defined. Capability is based on the number of times the process output failed (defect rate) or succeeded (yield). For more details, see Process Capability (Technique 37). 

Bothe DR, Measuring Process Capability, Techniques and Calculations for Quality and Manufacturing Engineers, McGraw-Hill, 1997. 

Statistical Process Control (SPC) The use of statistical techniques (such as control charts) to analyze a process and take appropriate action to maintain statistical control and improve process capability. 

From the above discussion, it follows that the quality and conformance to tolerance of the product characteristics should be designed in and not left to the process engineer and quality engineer to increase to the required level. In order to do this, designers need to be aware of potential problems and shortfalls in the capability of their designs. They therefore need a technique which estimates process capability and quantifies design risks. 

Are mechanisms in place to identify the need for statistical techniques required for verifying the acceptability of process capability and product characteristics ... 

Where process capability relies upon the competence of personnel, personnel operating such processes need to be appropriately educated and trained and undergo examination of their competency. Where there is less reliance on personnel but more on the consistency of materials, environment, and processing equipment, operations should be monitored continuously by inspection, observation, or other techniques. 

The standard does not require you to use statistical techniques but identify the need for them. Within your procedures you will therefore need a means of determining when statistical techniques will be needed to determine product characteristics and process capability. One way of doing this is to use checklists when preparing customer specifications, design specifications, and verification specifications and procedures. These checklists need to prompt the user to state whether the product characteristics or process capability will be determined using statistical techniques and if so which techniques are to be used. 

Literature in the area of neural networks has been expanding at an enormous rate with the development of new and efficient algorithms. Neural networks have been shown to have enormous processing capability and the authors have implemented many hybrid approaches based on this technique. The authors have implemented an ANN based approach in several areas of polymer science, and the overall results obtained have been very encouraging. Case studies and the algorithms presented in this chapter were very simple to implement. With the current expansion rate of new approaches in neural networks, the readers may find other paradigms that may provide new opportunities in their area of interest. 

Failure analysis using modern techniques such as finite element stress analysis and fracture mechanics Metallurgical and weld analysis Chemical engineering and process capability Quality assurance... 

The instrumental analytical techniques, developed in the last three or four decades, are almost all based on the limited signal and data processing capabilities of relatively simple analog instruments, and utilize a limited or simple theoretical basis for calculations. Apart from the rather advanced application of statistics, only a modest use of mathematical techniques in analytical chemistry has been used in these traditional analyses. 

In general, processes capable of inactivating viral or other pathogens (e.g. heat or chemical treatment) may not be applied to whole blood or most blood-derived products. Thus, for whole blood at least, effective screening of donations is exclusively relied upon to prevent pathogen transmission. Many of the processing techniques used to derive blood products from whole blood (e.g. precipitation, but especially chromatographic purification) can be effective in... 

Instrumentation advances have increased the power and quality of the fundamental analytical techniques used in conjunction with LIMS. Unfortunately, these advances come at a price of increasing complexity and volume of information. Despite all of the architectural and technological advances of computer hardware and software, the demands of the information requirements still exceed the computing capabilities, so as to put continuing pressure on computer manufacturers to increase storage and processing capabilities even further. 

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