Alec Dorling

The Gamification of SPICE

Process Improvement has been used for decades as a means to become better and more efficient. Whilst many organizations have used considerable resources for process improvement, investments in process improvement have not always led to changes and improvements expected. One most important aspects of management is to motivate the work force. However, management often fails to deliver. In fact, because management often uses extrinsic incentives to motivate their work force, it often ends up decreasing people’s intrinsic motivation to work. The transformational moment has arrived where we need to re-think the traditional ways to foster engagement in process improvement. Gamification offers a solution for transformational change. By using game psychology and the principles of gamification it is possible to translate the traditional enthusiasm for play and social media engagement into the workplace as a basis for both succeeding with and accelerating the uptake of improvement. Gamification as a solution offers the opportunity for better user engagement, faster feedback of achievement and more visible progress indicators of process improvement.

SPICE for SPACE trials, risk analysis, and process improvement

As part of a programme for software process improvement sponsored by the European Space Agency (ESA), an ISO 15504 (1998) conformant method for software process assessment has been developed. [Work supported under ESTEC Contract Number 10 662/93/NL/NB CCN5.] Called SPICE for SPACE, or S4S (Volcker and Cass 2002, Cass et al. 2000), the method includes an assessment model based on the ISO/IEC TR 15504 exemplar model with space software practices incorporated. To promote SPICE for SPACE, ESA has sponsored a series of trial assessments using the S4S method. Since February 2000, eight space software suppliers have been assessed in Austria, Belgium, Denmark, Germany, Great Britain, Italy, and Sweden. The first part of this paper describes the trial assessment programme to date, summarising the assessments that have taken place, the assessment results, the improvement efforts initiated in the host organisations, and the feedback gathered to improve the S4S method. The second part of this paper presents a new approach for software process improvement based on a risk analysis of assessment results. Developed within the same initiative, this method sets the basis for integrating process-oriented risk analysis into the S4S method, where, along with the process and capability dimensions, risk can be considered as a new third dimension. The outcomes of the risk analysis lead to the selection and prioritisation of pre-defined generic improvement actions. Alternatively, the risk analysis presented here can be applied in the context of supplier evaluation or risk estimation for investors in software organisations. Copyright

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.

SPiCE in action - experiences in tailoring and extension

Today the standard ISO/IEC TR 15504: software process assessment commonly known as SPiCE has been in use for more than 5 years, with hundreds of software process assessments performed in organizations around the world. The success of the ISO 15504 approach is demonstrated by its application in and extension to all sectors featuring software development, in particular, space, automotive, finance, healthcare, and electronics. As the current Technical Report makes the transition into an international standard, many initiatives are underway to expand the application of process assessment to areas even outside of software development. This paper reports on experiences in the use of ISO 15504 both in tailoring the standard for particular industrial sectors and in expanding the process assessment approach into new domains. In particular, three projects are discussed: SPiCE for SPACE, a ISO/IEC TR 15504 conformant method of software process assessment developed for the European space industry; SPiCE-9000 for SPACE, an assessment method for space quality management systems, based on ISO 9001:2000; and NOVE-IT, a project of the Swiss federal government to establish and assess processes covering IT procurement, development, operation, and service provision.

Development of MDevSPICE® - the medical device software process assessment framework

Software that is incorporated into a medical device, or which is a standalone medical device in its own right, is of a safety critical nature and subject to regulation from various jurisdictions. In order to satisfy jurisdictional regulations, developers of medical device software adopt standards and guidance provided by international standards bodies and regulators. However, the various standards and guidance documents are often not developed as a single cohesive set resulting in a complex and costly challenge for medical device software developers when complying with regulation.

MDevSPICE - A Comprehensive Solution for Manufacturers and Assessors of Safety-Critical Medical Device Software

Software development is frequently challenged with quality concerns. One of the primary reasons for such issues is the very nature of the software development process. First, it can be difficult to accurately and completely identify the requirements for a software development product. Also, the implementation on various platforms and the need to integrate with sometimes unforeseeable additional systems adds complexity. For safety critical domains, such as the medical device and healthcare sectors, these hurdles are amplified. Whereas a failure in a desktop application may be resolved through a restart with no harm incurred, a failure in a medical device can have life threatening consequences. Our work in the Regulated Software Research Centre (RSRC) aims to support medical device producers in the production of safer medical device software. In this paper, we describe the MDevSPICE framework and how it addresses the safety concerns faced by medical device producers.