An industrial case study: QbD to accelerate time-to-market of a drug product

The use of a Quality by Design (QbD) approach in the development of pharmaceutical products is known to bring many advantages to the table, such as increased product and process knowledge, robust manufacturing processes, and regulatory flexibility regarding changes during the commercial phase. However, many companies still adhere to a more traditional pharmaceutical process development—in some cases due to the difficulty of going from a theoretical view of QbD to its actual application. This article presents a real-world case study for the development of an industrial pharmaceutical drug product (oral solid dosage form) using the QbD methodology, demonstrating the activities involved and the gains in obtaining systematic process and product knowledge.

Interview Study on the Agile Development of Mechatronic Systems

In order to be as responsive as possible to changes in the dynamic context of mechatronic system development, companies are increasingly integrating agile approaches into their development processes. They are confronted with the challenges of adapting approaches that originate in software development to the conditions of physical development, without neglecting the experiences gained over many years regarding product and process knowledge. In addition, agile development approaches must be integrated into existing processes through a systematic implementation strategy. In order to gain an initial understanding of the current situation in mechatronic companies with regard to agile development approaches, an interview study was conducted with 18 participants from real development practice. This could show that the companies in mechatronic system development are currently at the beginning of agile transformation and need approaches that are modelled on the basis of real development projects and are best possible tailored to the needs of these companies through a clear technical orientation. The findings gained are not universally valid, but represent a basis for further research work.

Towards Holistic Traceability Solution

The purpose of traceability is to ensure persistent alignment of product knowledge between stakeholders, artifacts, and traceability objects. On the other hand, process knowledge is equally important to ensure a systematic software development process with accurate specification and verifiable quality attributes. Previous studies lacks in presenting a consolidated view from product and process knowledge perspectives. This study has taken a systematic literature review approach to evaluate sixty one previously published papers on traceability in leading journals and conferences. Based on the findings, the authors propose to extend the definition of an existing traceability meta-model to combine both product and process knowledge perspectives. The scope of this paper is to define the extension of the traceability meta-model without violating any of its statements. This study aims to contribute by taking steps towards defining a holistic model of traceability that will provide practical guidelines to IT practitioners in general and to process engineers in particular.

Knowledge Management and Customised 3D Modelling to Improve Prosthesis Design

This paper presents a new approach to design lower limb prosthesis focusing the attention on geometrical model issues. The new design approach has been developed within national and international research projects and, at present, “ad hoc” tools to carry out specific tasks are under development. Within this context, an important role is played by product and process knowledge and by specific CAD tools to design the most critical component, the socket. The paper discusses acquisition and formalisation of the knowledge related to the prosthesis design, with particular attention to the socket, and presents main features of a CAD tool specifically intended for this highly customised component.

An Exploratory Study on Knowledge Management Characteristics and Challenges in Mass Customisation

The characteristics of knowledge management (KM) in mass customisation were newly extracted and the effect of those characteristics on KM performance was examined through case studies in this research. The firms implementing mass customisation are good cases adopting recent changes in business environment including increased variability of customer needs, technologies, and increase of the need for KM. From the results of this research, several differentiated characteristics compared to the cases not implementing mass customisation were extracted. These include: (1) extended scope of KM (customer, product and process knowledge); (2) increase in the volume of knowledge and knowledge processes; and (3) increase in the need for knowledge flexibility and knowledge variability. In addition, it was found that the capability to manage these characteristics positively affected KM performance in mass customisation. Therefore, firms intending to implement KM for mass customisation need to consider the differentiated characteristics of KM. Research was conducted through interviews with company directors or managers in charge of KM in selected companies implementing mass customisation.

Requirement-Driven Design Processes With Integrated Knowledge Structures

Customer requirements provide objectives and constraints for all phases of the product development process. For complex system products with a high degree of customization, it is no mean task to ensure that the right persons at the right time have ready access to the selected requirement specifications that they should adhere to and strive to satisfy. In the present work a systematic sequence of development phases associated with computer implemented information structures for requirements, functions and systems have been studied at three companies with widely different products and business scenarios. Although individual adaptations are required, the overall processes for requirement decomposition and propagation appear surprisingly similar. To fully exploit the potential of such information systems, many companies would benefit from also including knowledge structures in their product models. Fundamental product and process knowledge often evolves slowly over time, can be gradually upgraded and be reused many times. It also constitutes one of the company’s most valuable assets and should be carefully maintained and enhanced. In the work presented here a few different approaches to integrating knowledge structures into the total product information structure have been developed and exemplified for the three companies studied.