Process Capability and

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. 

Murty, A. S. R. and Naikan, V. N. A. 1997 Machinery Selection - process capability and product reliability dependence. International Journal of Quality and Reliability Management, 14(4), 381-390. 

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

The standard requires the supplier to perform process studies on all new processes to verify process capability and provide additional input for process control. 

Process capability and related studies are addressed in Part 2 Chapter 9. 

Subcontractor development should not be limited to the assessment for compliance to ISO/TS 16949 as indicated in Note 1. The standard contains the minimum requirements and, with the requirement for continuous improvement, it may be necessary to work with some of your subcontractors in order to develop their capability to improve process capability and delivery schedules or reduce avoidable costs. You can t develop all your subcontractors and hence Note 2 of the standard indicates that you should prioritize subcontractors for development based upon performance and importance of product or service supplied. 

The standard requires suitable maintenance of equipment to ensure continuing process capability and to identity keg processes and provide appropriate resources for machine/equipment maintenance and develop an effective planned total preventive maintenance system. 

Following production launch, process capability and performance should be measured continually in order to demonstrate that your processes remain capable and the capability index continues to rise. Appropriate action should be taken on characteristics that are either unstable or non-capable. Action plans should be implemented to contain process output and continually improve performance. 

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. 

The following discussion will focus upon three areas of importance to successful utilization of an ICP. The three specific areas discussed are nebulizer design, spectral rejection and computer processing capability and have significant influence upon the quality and quantity of data obtained from an ICP-AES. These three features will significantly contribute to the analytical sample rate and the accuracy of the data. 

No less important are specifications issued by industrial consumers. Consumers are making purchasing decisions on the basis of the manufacturers processing capability and requiring the inspection of production control charts and data. 

The quality of design (product and its manufacturing process)—the ability to reliably predict quality and performance, process monitoring and controls, process capability and appropriate risk-mitigation strategies—provides an opportunity to achieve real time quality assurance (the ultimate level of efficiency). This also provides an excellent opportunity to develop efficient and effective quality assurance systems as an alternative to market or public standards (18). 

Assessment of process capability and statistical process control brings the ability to distinguish between a stable and un-stable process and provides a means to distinguish between different causes of variability, e.g., common cause, special cause, structural (e.g., seasonal), and tampering (e.g., deliberate or unintentional). Process understanding, quality by design and capability analysis can facilitate risk-based regulatory decisions for continuous improvements ... 

Robust processes will have owners that have defined roles, responsibilities, and accountabilities. These process owners must be fully dedicated to their process. They must know their process capabilities and expectations, the interrelationship between their process and other processes and manage them like a business unto themselves. Functional management must support process owners, and leadership must understand and lead the QMS effort as an ongoing program, treating it as the integral part of the business that it is. 

Sound data are developed by process development to determine the process capability and optimize the overall process. 

Figure 1 provides a validation time line that embraces this life cycle. Critical product specifications are determined chiefly by safety and efficacy (animal and human) studies. Critical process operating parameters are a function of process capability and are determined by process development, which includes process validation. Experienced process validation practitioners and regulators have learned repeatedly that just as quality must be built into a product (i.e., it cannot be tested in ) robustness also has to be built into a process. A robust process is a process that behaves in a stable manner even when minor changes occur to its critical process parameters. 

There are two sets of transfer functions one should be concerned with target settings and effects of variability.These are illustrated in Fig. 8, which shows the relationship between controllable inputs and their variability with the desired output and its variability. Thus, QFD defines how one flows the customer CTQs downwards, while the transfer functions define how one predicts process capability and defines the critical control points.The transfer functions allow the team to establish this linkage early in the development, rather than try to do it once products are in production. In addition when customer requirements change, the team does not have to begin a new project. With the transfer functions in hand, they can quickly evaluate capability and predicted reliability for the required process changes. 

Monolithic ceramic substrates have almost entirely been produced from cordierite which is a phase of the 2Mg0-2AL203-5S13 system. It has evolved as the industry standard because it combines the required properties, process capabilities and cost for this application. 

These developments have been fuelled in part by the apparently unrelenting increase in microcomputing power, bringing with it improved control and data acquisition and processing capabilities and partly by the improved technologies for the preparation of chromatographic media and packings in GC and LC, for example, chiral stationary phases, bonded phase capillary GC and narrow bore HPLC. 

---