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Product Quality and Process
Published in Wei-Shou Hu, Cell Culture Bioprocess Engineering, 2020
An important objective of process and product development is generating an understanding of process and product quality, and defining a strategy to monitor and control product quality during manufacturing. The variability of protein structures underlines the importance of identifying the properties whose variability affects the product’s safety and efficacy, and the need to control those properties within a defined range. In the early 2000s, the FDA published a series of documents on cGMP in the twenty-first century and began a drive to put QbD into drug development and manufacturing (Figure 4.9).7 Many of these documents, including ICH Q8 (R2) (Pharmaceutical Development), ICH Q9 (Quality Risk Management), ICH Q10 (Pharmaceutical Quality System), and ICH Q11 (Development and Manufacture of Drug Substance), provide high-level direction with respect to the scope and definition of QbD as it applies to the biologics industry. These documents also introduced a number of items that are listed in Panel 4.11.
Lean product development and design management
Published in Patricia Tzortzopoulos, Mike Kagioglou, Lauri Koskela, Lean Construction, 2020
Patricia Tzortzopoulos, Cynthia dos Santos Hentschke, Mike Kagioglou
Cooper (1994, p. 3) defines the New Product Development process as: ‘a formal blue print, road map, template or thought process for driving a new product project from the idea stage through to market launch and beyond’. According to Ulrich and Eppinger (2000), product development is the process through which a product is conceived, designed and launched in the market, and includes feedback from both production and product use. New Product Development begins with the perception of a market opportunity and typically involves the capture and management of customer requirements, concept development, product design, market launch and collection and dissemination of feedback data (Cooper et al., 1998; Yazdani and Holmes, 1999). Hence, it includes both product and production process design activities. This concept makes explicit the importance of design, but also the interfaces between design and production, through the links between information and physical production (Tzortzopoulos, 2004).
A Survey on Application of a System Dynamic Approach in Supply Chain Performance Modeling
Published in C. S. P. Rao, G. Amba Prasad Rao, N. Selvaraj, P. S. C. Bose, V. P. Chandramohan, Mechanical Engineering for Sustainable Development, 2019
K. Jagan Mohan Reddy, A. Neelakanteswara Rao, Lanka Krishnanand
Strategic decisions play a vital role in meeting the objectives of focal SC.20 These decisions are taken by top-level management through involving each level in SC. The strategic level measures influence the top level management decisions, very often reflecting investigation of broad based policies, corporate financial plans, competitiveness and level of adherence to organizational goals. This paper attempted to show the related literature at each decision level based on the performance metrics which have been used by researchers and academics. For last 20 years, a less number (16%) of authors have used the SD to model the SCP based on strategic metrics. Gunasekaran et al.20 have given the metrics at the strategic level, such as level of customer perceived value of the product, variances against budget, order lead time, information processing cost, net profit verses productivity ratio, total cycle time, total cash flow time, product development cycle time, and so forth. This paper has attempted to show the number of literature have used these metrics to model SCP through SD approach. For example Bolarin et al.5 used the dynamic model to predict the inventory costs consequences of variability demand process within a multi-stage SC consisting of supplier-manufacturer-distributor-retailer. They used Vensim software to relate inventory carrying cost for all the SC stages. Debabrata Das and Pankaj Dutta13 proposed framework can be used to understand the long-term behavior of a system under various managerial issues.
Product development, fashion buying and merchandising
Published in Textile Progress, 2022
Rachel Parker-Strak, Rosy Boardman, Liz Barnes, Stephen Doyle, Rachel Studd
New Product Development (NPD) is one of the key factors for progress and competitive advantage in helping all businesses to survive (Silinevica, Igavens, & Amantova-Salmane, 2016). A product-development process is a sequence of steps or activities that an enterprise employs to conceive, design, and commercialise a product (Ulrich & Eppinger, 2016). It incorporates tasks such as idea creation, market research, design, financial analysis, and product testing (Evans, 2014).t As such, NPD is the term given to the process whereby original ideas are transformed into specific products through design, sourcing, manufacturing and distribution activities. Thus, the entire process of product development ranges from conception to commercialisation and is one of the fundamental procedures that business operations are focused around. Therefore, NPD is defined as the transformation of a market opportunity and a set of assumptions about product technology into a product available for sale (Krishnan & Ulrich, 2001).
From the Editors
Published in Engineering Management Journal, 2018
Heather Nachtmann, Edward Pohl
Our issue begins with an article entitled “Examining State of Risk Management Research in New Product Development Process” by Chauhan, Nepal, Soni, and Rathore. Their article benefits engineering managers by identifying and organizing the new product development risk management literature in order to formulate appropriate risk mitigation strategies and support better informed decisions. The authors provide an integrated framework for addressing risk encountered in new product development projects and to identify the most appropriate approach by adapting a given methodology or combining techniques for improved risk management. Their presented framework can provide a path towards holistic risk management in new product development processes.
Modular architecture principles – MAPs: a key factor in the development of sustainable open architecture products
Published in International Journal of Sustainable Engineering, 2020
Jaime Alberto Mesa, Iván Esparragoza, Heriberto Maury
The product development process comprises the idea generation, design, and materialization or manufacture of a product that satisfies a specific need within a market segment. These activities are common to all manufacturing companies, which transform raw material and resources in a useful product. This transformation from raw material to the final product is one of the most significant generators of negative impacts in the sustainability during a product development due to depletion of resources, pollution, emissions and consumption of energy among others.