Marion Lepmets

Goal alignment in process improvement

Highlights? We evaluate the impact of process assessment on the success of process improvement. ? Focus on aligning process goals to organisations business goals in process improvement. ? Data from 63 IT organisations conducting process improvements were analysed. ? Results indicate a severe lack of knowledge in goal alignment in practice. ? Industry needs guidance on how to align process goals and organisations goals. Process improvement should improve an organisations ability to achieve its business goals. While mapping an organisations strategic goals through various layers of management is common, such mapping does not seem to continue through to their processes that create value to the organisation. Despite a number of process improvement methods being available, and almost two decades of experience with those methods, many process improvement projects do not end successfully.We explore the impact process assessment has on process improvement. In particular, we study the alignment of an organisations process goals to its business goals; and the contribution of process assessment to this goal alignment. This paper illustrates the data gathered through industry survey reflecting the lack of focus on and alignment of organisations business goals throughout process improvement. The results indicate that there is little knowledge and experience in industry in aligning the process goals and organisations business goals. This, in turn, could explain the unsuccessful process improvement efforts or perhaps even the skepticism towards process improvement in general.

Extending the IT service quality measurement framework through a systematic literature review

Continuous improvement of service quality results in enhanced customer satisfaction, increased efficiency and maximisation of business value of the service within the company. Decision-making on the course of service quality improvement is based on the current status of the measurable service quality attributes. The aim of the paper is to describe the IT service quality attributes that could be measured to improve IT service quality. We report on a systematic literature review of IT service quality measurement. The review was based on 134 relevant journal articles related to IT service quality management. Of these, 91 articles were selected for analysis. We propose a detailed and comprehensive quality measurement framework for IT services using the results of the systematic literature review to extend previous work. The framework presents six common issue areas with their associated measurement categories, measures, and indicators. IT service providers can choose the measures to satisfy their specific information needs from the proposed IT service quality measurement framework. We conclude that IT service quality improvement efforts could benefit from considering the internal IT service quality attributes from the viewpoint of the value the provided IT service could bring to both the customer and the provider.

Harmonizing Software Development Processes with Software Development Settings - A Systematic Approach

The software process landscape is rich in complexity and many alternative software development approaches have emerged over the past 40 years. However, no single software development approach is universally implemented and it seems likely that no single approach can be universally useful. One of the primary reasons that no single approach is universally useful is that no two software development settings are identical. We have assembled a team of recognized academics, who together with industrial collaborators, plan to map the complex world of software processes with the context of software development projects. The results of our initial mapping efforts, reported in this paper, demonstrate that although there are challenges in an undertaking such as this, the outcomes are potentially of considerable value to both software researchers and practitioners.

A Quality Measurement Framework for IT Services

Our research aims to evaluate the impact of process improvement on IT service quality by conducting a series of studies in industry. In order to do that we first establish a framework for IT service quality measures and indicators. Stemming from the fact that you cannot improve what you cannot measure, this paper proposes IT service quality measures. We adapt two widely known quality measurement frameworks of software engineering to IT services. We apply the software product quality model described in ISO/IEC 25010 and the quality measurement framework of Practical Software and Systems Measurement to the IT service quality attributes, which are derived from ITIL, ISO/IEC 20000 and SERVQUAL. As a result of the study, we will have IT service quality measures that industry can collect in order to evaluate their progress.

Safety Critical Software Process Assessment: How MDevSPICE® Addresses the Challenge of Integrating Compliance and Capability

One of the primary outcomes of a software process assessment is visibility of the capability of a software process which among other things, informs us of the ability of a process to deliver consistent product quality levels. In safety critical domains, such as the medical device sector, high product quality – and particularly high product safety - is an important consideration. To address this safety concern, the medical device sector traditionally employs audits to determine compliance to software process standards and guidance. Unlike an audit which results in a pass/fail outcome, an assessment provides a process capability profile which identifies areas for improvement and enables a comparison with broader best practice. MDevSPICE® integrates the various medical device software standards and guidance within the infrastructure of a SPICE assessment model, thus encompassing aspects of compliance and capability. This paper describes some of the key enablers of this integration.

Piloting MDevSPICE: the medical device software process assessment framework

Software development companies moving into the medical device domain often find themselves overwhelmed by the number of regulatory requirements they need to satisfy before they can market their device. Several international standards and guidance documents have been developed to help companies on their road to regulatory compliance but working their way through the various standards is a challenge in itself. In order to help software companies in the medical device domain, we have developed an integrated framework of medical device software development best practices called MDevSPICE®. This framework integrates generic software development best practices with medical device standards’ requirements enabling consistent and thorough assessment of medical device processes. MDevSPICE® can be used by software companies evaluating their readiness for regulatory audits as well as by large medical device manufacturers for selecting suitable software suppliers. The MDevSPICE® framework consists of a process reference model, a process assessment model, an assessment method, and training and certification schemes. The framework has been validated using expert reviews and through MDevSPICE® assessments in industry. In this paper, we describe the MDevSPICE® process assessment framework focusing on its benefits and significance for the medical device manufacturing community as learned from MDevSPICE® assessments conducted to date.

Development of a Process Assessment Model for Assessing Medical IT Networks against IEC 80001-1

Increasingly medical devices are being designed to allow them to exchange information over an IT network. However incorporating a medical device into an IT network can introduce risks which can impact the safety, effectiveness and security of the medical device. Medical devices are stringently tested according to regulation during the design and manufacture process. However until the introduction of IEC 80001-1: Application of Risk Management for IT-Networks incorporating Medical Devices, no standard addressed the risks of incorporating a medical device into an IT network. In order to perform an assessment (which is compliant with ISO/IEC 15504-2) of an IT network against IEC 80001-1, a Process Assessment Model is required. Based on the relationship between IEC 80001-1 and ISO/IEC 20000-1, this paper examines how the TIPA transformation process developed by Public Research Centre Henri Tudor was used to develop a process assessment model (TIPA PAM) for ISO/IEC 20000-1. It also examines how a process assessment model can be developed following that transformation process to assess Medical IT networks against IEC 80001-1.

A Cynefin Based Approach to Process Model Tailoring and Goal Alignment

In an industrial context all process models require a certain amount of tailoring to fit to the business environment of any specific organization in which the model is to be deployed. Process models should therefore be accompanied by tailoring guidelines and approaches to assist with strategic and operational goal alignment that support their use in industry. This paper explores shortcomings of process improvement and the existing process models, suggesting that a more holistic approach should be taken to process improvement in the modern organization. The paper provides an overview of systems thinking and the Cynefin framework that organizations can use to detect the characteristics of the domain in which they are operate. Knowing their domain helps the organization realize the amount of tailoring and goal alignment necessary to benefit from implementing process model guidance.

A Lightweight Assessment Method for Medical Device Software Processes

This paper outlines the MDevSPICE-Adept process assessment method. MDevSPICE-Adept is a lightweight process assessment method that has been created for the MDevSPICE software process assessment model which is currently being developed for the medical device industry. MDevSPICE is a fully validated release of a medical device software process assessment model (formerly known as Medi SPICE), which was developed by the authors. While the MDevSPICE process assessment model is detailed and comprehensive, there is industry demand for a lightweight medical device software process assessment method. To address this requirement the MDevSPICE-Adept method has been developed. Details on how this has taken place and the procedures for implementing an MDevSPICE-Adept process assessment are presented. Information is also provided regarding how an MDevSPICE process assessment was undertaken in an Irish based medical device company. A summary of the issues identified from this process assessment and the actions taken to facilitate process improvement is also presented. Finally, plans for future work are discussed.

Motivation and Empowerment in Process Improvement

Clarity in goals, tasks, and responsibilities empowers employees to undertake an organizational change. Assessing processes prior to process improvement allows high involvement in setting the improvement goals, awareness of the organization’s business goals, and understanding the roles and responsibilities in process improvement. This study describes the results of an international survey about goal internalization, motivation, and empowerment in process improvement. The results indicate that process assessment contributes to the goal internalization of process improvement. However, process assessment alone does not contribute extensively to the empowerment and motivation of employees.