Product development process

The relationship is commonly known as the TOx rule and is shown in Figure 1.13. The 10 X rule demonstrates how a fault, if not discovered, will give rise to ten times the original elimination costs in a later phase of the life-cycle. In other words, products must be designed in such a way that scarcely any defects develop or if they do, they can be identified as early as possible in the product development process and rectified (Braunsperger, 1996). Other surveys have found that these costs could be even higher as shown in Figure 1.14. 

Variability prediction - A key objective of the analysis is predicting, in the early stages of the product development process, the likely levels of out of tolerance variation when in production. 

It must be adaptable as the situations within every organization are different and a uniform product development process will not capitalize on the strengths of individual enterprises or address the weaknesses. 

The Toyota X300 fork lift truck project design cycle is concurrent in nature spanning all the major disciplines in the process with quality assurance reviews, stipulating the use of appropriate tools and techniques at certain points. The product development process produced by General Electric is called the Tollgate Process . Again, it is concurrent in nature and includes ten review points. 

A summary of each of the key tools and techniques considered to be important in the product development process is given in Appendix III. This covers such techniques as FMEA, QFD, DFA/DFM and DOE. Included for each is a description of the tool or technique, placement issues in product development, key issues with regard to implementation, and the benefits that can accrue from their use, and finally a case study. It would be advantageous next, however, to determine exactly what a tool or technique does. In general, the main engineering activities that should be facilitated by their use are (Huang, 1996) ... 

The integration of tools and techniques in the product development process... 

When a single technique is employed only local life-cycle cost minimization is achieved. If the global life-cycle cost is to be minimized, a number of techniques have to be applied (Watson et al., 1996). In this case, tools and techniques shouldn t compete with each other, but be complementary in the product development process. The correct positioning of the various off-line tools and techniques in the product development process, therefore, becomes an important consideration in their effective usage. Patterns of application have been proposed by a number of workers over several years (Brown et al., 1989 Jakobsen, 1993 Norell, 1993) and the importance of concurrency has been highlighted as a critical factor in their use (Poolton and Barclay, 1996). 

Before setting about the task of developing such a model, the product development process requires definition along with an indication of its key stages, this is so the appropriate tools and techniques can be applied (Booker et al., 1997). In the approach presented here in Figure 5.11, the product development phases are activities generally defined in the automotive industry (Clark and Fujimoto, 1991). QFD Phase 1 is used to understand and quantify the importance of customer needs and requirements, and to support the definition of product and process requirements. The FMEA process is used to explore any potential failure modes, their likely Occurrence, Severity and Detectability. DFA/DFM techniques are used to minimize part count, facilitate ease of assembly and project component manufacturing and assembly costs, and are primarily aimed at cost reduction. 

The so-called Q7 tools and techniques, Cause and Effect Diagrams, Pareto Analysis, etc. (Bicheno, 1994 Dale and McQuater, 1998 Straker, 1995), are applicable to any stage of the product development process. Indeed they support the working of some of the techniques mentioned, for example using a Pareto chart for prioritizing the potential risks in terms of the RPN index for a design as determined in FMEA (see Appendix III). 

A proposed product development process that facilitates designing capable and reliable products has been outlined above. It must be stressed that the product development process itself will not produce quality products, and consideration of many issues are crucial to success, such as company strategy, management structure, commitment, sufficient resources, communication, and most importantly proficient engineering practices, such as the following. 

Tools and techniques can enhance the success of a product, but alone they will not solve all product development issues (Jenkins et al., 1997a). Any implementation of tools and techniques within the product development process must take the following into account if the outcome is to be effective at all ... 

TQM affects three areas of the product development process (Rosenau and Moran, 1993) ... 

Technical - thought of as a toolbox, techniques used to facilitate TQM and the product development process. 

A key success factor for reducing the costs and lead times for vehicle manufacturers, for example, is the degree of integration of the suppliers within the product development process. This is seen as a natural extension to concurrent engineering principles (Wyatt et al., 1998). For many years, in engineering companies, a substantial proportion of the finished product, typically two thirds, consists of components or subassemblies produced by suppliers (Noori and Radford, 1995). 

Jenkins, S., Forbes, S., Durrani, T. S. and Banerjee, S. K. 1997a Managing the Product Development Process - Part I an assessment. International Journal of Technology Management, 13(4), 359-378. 

Norell, M. 1993 The Use of DFA, FMEA, QFD as Tools for Concurrent Engineering in Product Development Processes. In Proceedings ICED 93, The Hague. 

To improve customer satisfaction and business competitiveness, companies need to reduce the levels of non-conformance and attendant failure costs associated with poor product design and development. Attention needs to be focused on the quality and reliability of the design as early as possible in the product development process. This can be achieved by understanding the potential for variability in design parameters and the likely failure consequences in order to reduce the overall risk. The effective use of tools and techniques for designing for quality and reliability can provide this necessary understanding to reduce failure costs. 

Comprehensive physicochemical characterization of any raw material is a crucial and multi-phased requirement for the selection and validation of that matter as a constituent of a product or part of the product development process (Morris et al., 1998). Such demand is especially important in the pharmaceutical industry because of the presence of several compounds assembled in a formulation, such as active substances and excipients, which highlights the importance of compatibility among them. Besides, variations in raw materials due to different sources, periods of extraction and various environmental factors may lead to failures in production and/or in the dosage form performance (Morris et al., 1998). Additionally, economic issues are also related to the need for investigating the physicochemical characteristics of raw materials since those features may determine the most adequate and low-cost material for specific procedures and dosage forms. 

The EPS system was initially developed to be used within the product development process as a tool to help assess the environmental performance of products. The system is based on LCA (Life Cycle Assessment) methodology and uses inventory data (kg of substance A), characterization factors (impact/kg of substance X) and weighting factors (cost/impacts) to calculate the external costs or values of a product. By multiplying the characterization factor with the weighting factor, an impact index is obtained (cost/kg of substance X) which describe the cost/values related to the emission per use of a kg of a certain substance. 

The ELISA is a versatile method that can be used throughout the biopharmaceutical product development process, from small-scale research to cell-line selection, to monitoring fermentation and downstream processing, and to product release testing. The use of the microtiter plates allows for high sample throughput and various degrees of automation. ELISAs satisfy the biopharmaceutical production requirements for specific, accurate, precise, and reproducible assays. 

Since the mid-1990s, many new niche contractors were established by capitalizing on advances in information technology (IT). The therapeutic product development process includes clinical trials that are extremely complex, and many funchons can be dramatically improved by applying customized IT applications. 

The commercial assessment of NCEs (or biologic entities as well, although for simplicity we will only reference the former in the description that follows) should be an integral part of the new product development process, with three key questions in mind ... 

Stock/flow methodology provides a visual framework to conceptualize the new product development process. 

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