Derek Flood

The Barriers to Traceability and their Potential Solutions: Towards a Reference Framework

Traceability of software artifacts, from requirements to design and through implementation and quality assurance, has long been promoted by the research and expert practitioner communities. However, evidence indicates that, with the exception of those operating in the safety critical domain, few software companies choose to implement traceability processes, often due to associated cost and complexity issues. This paper presents a review of traceability literature including the implementation of traceability in real organizations. Through both analyzing case studies and research published by leading traceability researchers, this paper synthesizes the barriers faced by organizations while implementing traceability, along with proposed solutions to the barriers. Additionally, given the importance of traceability in the regulated domain of safety critical software, the paper compares the barriers for organizations operating inside and outside of this domain.

A Traceability Process Assessment Model for the Medical Device Domain

Traceability of requirements through the software development lifecycle (including supporting processes such as risk management and change management) is a difficult and expensive task. The implementation of effective traceability allows organizations to leverage its many advantages, such as impact analysis, product verification and validation, and facilitation of code maintenance. Traceability is conducive to producing quality software.

Evaluating Mobile Applications: A Spreadsheet Case Study

The power of mobile devices has increased dramatically in the last few years. These devices are becoming more sophisticated and allow users to accomplish a wide variety of tasks while on the move. The ease with which mobile apps can be created and distributed has resulted in a number of usability issues becoming more prevalent. This paper describes the range of usability issues encountered at all stages of the mobile app life cycle, from when users begin to search for an app to when they finally remove the app from their device. Using these results the authors developed a number of guidelines for both app developers and app platform developers that will improve the overall usability of mobile apps.

A roadmap to ISO 14971 implementation

Medical device standards outline the requirements for developing medical devices. These standards, however, do not outline how these requirements should be implemented causing difficulties for organisations entering the medical device domain.

A Methodology for Software Process Improvement Roadmaps for Regulated Domains – Example with IEC 62366

Software process improvement initiatives offer many benefits in terms of productivity, cost savings and quality. As part of these initiatives organisations undergo an assessment and then embark on a software process improvement program to improve their existing processes to meet a desired target. These programs can be improved by the use of process improvement roadmaps that are tailored to the organisation and are usually non-transferrable. Within regulated domains, such as the medical device industry, adherence to international standards must be achieved before products can be placed on the market. This work proposes the use of software process improvement roadmaps to assist organisations achieve compliance with medical device standards. These proposed roadmaps will be generic in nature to meet the requirements of the standard, but will be subsequently tailored to meet the specific requirements of an individual organisation. In this paper we introduce the concept of the software process improvement roadmaps for the implementation of standards and detail a methodology for developing these roadmaps.

Assessing traceability-practical experiences and lessons learned

Most existing software systems that lack explicit traceability links between artefacts, or if implemented, are often not leveraged to take advantage of the information it can provide to a development or validation team.

The Development and Validation of a Traceability Assessment Model

Regulation normally requires critical systems to be certified before entering service. This involves submission of a safety case - a reasoned argument and supporting evidence that stringent requirements have been met and that the system is acceptably safe. A good safety case encompasses an effective risk mitigation process which is highly dependent on requirements traceability. However despite its many benefits and regulatory requirements, most existing software systems lack explicit traceability links between artefacts. Reasons for the lack of traceability include cost, complexity and lack of guidance on how to implement traceability.To assist medical device organisations in addressing the lack of guidance on how to implement effective traceability, this paper aims to present the development and validation of a traceability process assessment model and the actions to be taken as a result of the validation. The process assessment model will allow organisations to identify strengths and weaknesses in their existing traceability process and pinpoint areas for improvement.

Investigation of Traceability within a Medical Device Organization

Requirements traceability helps to ensure software quality. It supports quality assurance activities such as impact analysis, regression test selection, compliance verification and validation of requirements. Its implementation has long been promoted by the research and expert practitioner communities. However, evidence indicates that few software organizations choose to implement traceability processes, in the most part due to cost and complexity issues. Organizations operating within the safety critical domains are mandated to implement traceability, and find the implementation and maintenance of an efficient and compliant traceability process a difficult and complex issue. Through interviews with a medical device SME, this paper seeks to determine how traceability is implemented within the organization, the difficulties it faces in implementing traceability, how compliant it is with the medical device standards and guidelines, and what changes could be made to improve the efficiency of their traceability implementation and maintenance.

Research findings from an industrial trial of a traceability assessment and implementation framework

Software systems are becoming increasingly complex. Withinsafety critical domains such as medical device software, thisincreasing complexity is placing growing demands onmanufacturers who must ensure their software not only meetsfunctional requirements but is also safe and reliable. However, theFood and Drugs Administration who regulate medical devicesoftware in the United States report a significant increase inrecalls between years 2003 and 2012 and have cited softwaredifficulties as one of the frequent causes of recalls. Furthermore arecent analysis of traceability documentation submitted to theAdministration has revealed that the traceability data wasincomplete, incorrect, and conflicting in many cases. This isproblematic as traceability plays an important role in thedevelopment of safe and reliable software. In this paper wepresent the validation, through industry trial, of a traceabilityassessment and implementation framework which we havedeveloped to assist medical device organizations implementtraceability in an efficient and regulatory compliant manner. Ourfindings show that implementation of the framework within twoorganizations improved their traceability process and that bothorganizations found the framework to be both useful and usable.

Software Process Improvement and Roadmapping – A Roadmap for Implementing IEC 62304 in Organizations Developing and Maintaining Medical Device Software

Organizations engaged in medical device software are required to demonstrate compliance with a set of medical device standards and regulations before the device can be marketed. One such standard IEC 62304, Medical device software – Software life cycle processes, is a standard that defines the processes that are required to be executed in order to develop safe software. Demonstrating compliance with IEC 62304 can be problematic for organizations that are new to or have limited experience in the domain. The standard defines what processes must be carried out, but does not state how. This paper presents a research method for generating a roadmap that will guide organizations in the implementation of IEC 62304.