Product and process improvement

The enterprise shall monitor product and process quality factors and shall continuously improve products and processes throughout the system life cycle, as described in the following subclauses. 

The enterprise should explore ways to improve existing products and processes. The enterprise should capture the design data, schema, tools, and models related to each developmrait effort and design in the capacity to evolve a product or process in order to improve system cost effectiveness and to correct deficiencies. 

The enterprise shall maintain a self-assessment program to determine the maturity of its systems engineering practices to include the application of the SEP tasks of Clause 6. The raiterprise applies insights gained during self-assessment toward improving products, life cycle processes, and enterprise systems engineering practices. 

The enterprise shall capture the lessons learned on each project and incorporate them into enterprise training courses, as appropriate, to improve the application of the SEP. Lessons learned provide a basis for establishing future system development efforts, for improving metrics, and for avoiding problems encountered by previous projects undertaken by the enterprise. 

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Metabolic and enzyme engineering have received a lot of attention in academic institutions and are now being applied for the optimization of biocatalysts used in the production of a diverse range of products. Engineered microorganisms, even with non-native enzyme activities, are being used for novel products and process improvements for the production of precursors, intermediates and complete compounds, required in the pharmaceutical industry (Chartrain et ai, 2000). 

Roy, Ranjit K (2001), Design of Experiments Using The Taguchi Approach 16 Steps to Product and Process Improvement (New York John Wiley Sons) 531. 

Provides a viable mechanism for continuous improvement to forward quality. Change can be a big contributing factor toward continuous improvement. A good system gives you a systematic, documented way to evaluate and incorporate product and process improvements. 

The chemical industry has a long history of product and process innovation and has provided enormous benefits to society. Since the late 19th century the industry has continually developed new products and processes, improved its functionality and cost-effectiveness, and displaced many traditional materials. Its products are now integrated into many economic sectors and it has a history of collaborating with its customers to develop innovative solutions. As a result there has been a dramatic increase in the use of chemicals and plastics, and these have provided tremendous cost savings as well as improved functionality (Sherman, Chapter 4, Section 4.6 of this volume). Safer and more efficient automobiles, and large-scale... 

Companies such as Rhino and Au Bon Pain can keep their product and process improvements separate. Robust supply chain processes can handle all the types of entertainment and sandwich variations that are likely to be encountered. B and C product development efforts should formally consider the impact on the supply chain. Will it require a B, C, or D response from supply chain managers Or does it require none at all If it does require a B, C, or D response, then a concurrent engineering effort should be initiated. Chapter 29 describes tools for a CE effort. 

The quality of the design has to be monitored, with help of a regular review of results of analysis, complaints, recalls etcetera. In order to frame that activity into the PQS, the term Product quality review is used. GMP Chap. 1 emphasises the importance of product evaluation an annual evaluation of product quality for every product, and a risk analysis as well. A Product Quality Review has the objective of verifying the consistency of the existing process, the appropriateness of current specifications for both starting materials and finished product, to highlight any trends and to identify product and process improvements . 

The reader wUl have noted that many production aspects for existing vaccines are quite archaic. This is so because most vaccines were developed before the biotechnology revolution, which is creating a generation of highly purified and better-characterized subunit vaccines. As such, for older vaccines the process defines the product, and process improvements cannot readily be incorporated into these poorly characterized vaccines without extensive new clinical trials. With improved scientific capabilities, we can... 

Stages and gates, an approach developed by Robert Cooper, will improve supply chain planning in companies with numerous projects. ln these situations, the projects are usually of different sizes and priorities. They are moving at different paces through a product development "pipeline." While many companies already use some form of the technique, that use is often confined to the technical side of the development process. We believe the stage and gate technique suits both product and process improvement. 

Ranjit, K.R., Roy, R.K., 2001. Design of experiments using the Taguchi approach 16 steps to product and process improvement / Ranjit K. Roy, Wiley, New York. 

During the 1930s gradual improvements in the product and processing overcame some of the drawbacks of this material. Nonetheless, the apphcations were limited and Thiokol Corp. stmggled to remain solvent. The first year Thiokol reported a profit was in 1941, 13 years after its foundation. This was realized when the U.S. Air Force discovered that the aUphatic polysulftdes were usehil as a fuel-resistant sealant for aircraft tanks and hoses. Polysulftdes also began to be used as sealants for boat hulls and decks. 

Although carbon electrode production has been regarded as a mature business, the steady growth in demand and the need for improved electrodes has prompted ongoing development efforts in these areas (/) cost containment through raw material substitutions and process improvements (2) higher purity electrodes for those processes such as siUcon production (J) improvements in thermal shock resistance to enhance electrode performance and (4) better joining systems for prebakes. 

In a few apphcations, improving the control system leads to a reduction in orf-specification product and thus improved process economics. However, in most situations, the process is operated sufficiently far from the constraint that very little, if any, off-specification produc t results from control system deficiencies. Management often places considerable emphasis on avoiding off-spec production, so consequently the target is ac tuaUy set far more conservatively than it should be. 

Product and process quality will be improved as a result of implementing several new requirements, including ... 

Productivity is addressed under Continuous improvement and in order to improve productivity you will need to collect data generally in the form of resource/part produced. Resource can be hours, costs, weight, or volume of material consumed. Graphs showing the productivity trend over time for plants, products, and processes would satisfy this requirement. 

This requirement illustrates some ambiguity over terminology. Clause 4.1.1.4 mentions improvement in quality which implies improvement in product and process characteristics, thereby making this additional requirement superfluous. Little more is needed than was given in Part 2 Chapter 1 except to state that when setting priorities for improvement you need to focus on the special characteristics first. 

There are some applications for a-sulfo fatty acid esters in the production and processing of synthetic materials or natural rubber. Emulsifiers are needed for the emulsion polymerization, antistatic agents improve the properties of polymers, and wetting agents are needed as parting components for elastomers. 

Over the past 30 years, the world food production has grown faster than the population, the major basis of consumption. The world food production increased at an annual rate of 2.4% (grain production increased at 2.7%), while the world population increase is now less than 2% (9). Research and improved technologies have contributed to an increase in food availability, which will continue if an appropriate political, social, and economic environment exists. The world population, now at 5.5 billion, is predicted to be 10 billion in the last quarter of the next century (9) and will place greater demands on the production and processing of food. 

Probably the most fundamental problem facing the development of greener products and processes is the measurement of progress and the development of appropriate methods for comparison of alternatives. In many instances it will be obvious that improvements have been made, for example when a toxic material is replaced by a non-toxic alternative, keeping all other process conditions essentially the same, or when the energy requirement of a process is reduced. 

In the preceding chapters some of the main chemical developments that can help reduce waste, lower harmful emissions, improve process efficiency and generally aid development of more sustainable products and processes were discussed. In this and the following chapter the focus will be more on those aspects of technology that can lead to improved process and energy efficiency as well as process cost reduction. 

Therefore, in this definition process intensification encompasses both novel apparatus and techniques which are designed to bring dramatic improvements in production and processing (Figure 1.8) [25]. As a result, safe, cheaper, compact, sustainable (environmentally friendly), and energy-efficient technologies are obtained. 

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