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.
{"title":"Piloting MDevSPICE: the medical device software process assessment framework","authors":"Marion Lepmets, F. McCaffery, Paul M. Clarke","doi":"10.1145/2785592.2785598","DOIUrl":"https://doi.org/10.1145/2785592.2785598","url":null,"abstract":"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.","PeriodicalId":415950,"journal":{"name":"Proceedings of the 2015 International Conference on Software and System Process","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2015-08-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129025836","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Logistics processes are generally automated, agreed-upon, long running propositions between multiple partners, that are specified over Service Level Agreements as constraints to be maintained. However, these constraints can be violated at any time due to various unforeseen events that may stem from the process evolving context. In this paper, we present a framework along with a demonstration software that correlates critical business operations together with contextual events in order to predict possible violations prior to their occurrences while proactively generating mitigation countermeasures.
{"title":"Towards smart logistics processes: a predictive monitoring and proactive adaptation approach","authors":"Raef Mousheimish, Y. Taher, Béatrice Finance","doi":"10.1145/2785592.2794403","DOIUrl":"https://doi.org/10.1145/2785592.2794403","url":null,"abstract":"Logistics processes are generally automated, agreed-upon, long running propositions between multiple partners, that are specified over Service Level Agreements as constraints to be maintained. However, these constraints can be violated at any time due to various unforeseen events that may stem from the process evolving context. In this paper, we present a framework along with a demonstration software that correlates critical business operations together with contextual events in order to predict possible violations prior to their occurrences while proactively generating mitigation countermeasures.","PeriodicalId":415950,"journal":{"name":"Proceedings of the 2015 International Conference on Software and System Process","volume":"4 1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2015-08-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116809115","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
An agile software development process is often claimed to increase productivity. However, productivity measurement in agile software development is little researched. Measures are not explicitly defined nor commonly agreed upon. In this paper, we highlight the agile productivity measures reported in literature by means of a research method called scoping study. We were able to identify 12 papers reporting the productivity measures in agile software development processes. We found that finding, understanding and putting into use agile productivity definitions is not an easy task. From the perspective of common roles in agile software development process and existing knowledge workers’ productivity dimensions, we also emphasize that none of the productivity measures satisfy these fully. We recommend that future effort should be focused on defining agile productivity in measurable, practicable and meaningful form.
{"title":"Measuring productivity in agile software development process: a scoping study","authors":"S. M. A. Shah, Efi Papatheocharous, Jaana Nyfjord","doi":"10.1145/2785592.2785618","DOIUrl":"https://doi.org/10.1145/2785592.2785618","url":null,"abstract":"An agile software development process is often claimed to increase productivity. However, productivity measurement in agile software development is little researched. Measures are not explicitly defined nor commonly agreed upon. In this paper, we highlight the agile productivity measures reported in literature by means of a research method called scoping study. We were able to identify 12 papers reporting the productivity measures in agile software development processes. We found that finding, understanding and putting into use agile productivity definitions is not an easy task. From the perspective of common roles in agile software development process and existing knowledge workers’ productivity dimensions, we also emphasize that none of the productivity measures satisfy these fully. We recommend that future effort should be focused on defining agile productivity in measurable, practicable and meaningful form.","PeriodicalId":415950,"journal":{"name":"Proceedings of the 2015 International Conference on Software and System Process","volume":"2 2","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2015-08-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131450972","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Agile development processes are popular when attempting to respond to changing requirements in a controlled manner; however, selecting an ill-suited process may increase project costs and risk. Before adopting a seemingly promising agile approach, we desire to evaluate the approach's applicability in the context of the specific product, organization, and staff. Simulation provides a means to do this. However, in order to simulate agile processes we require both the ability to model individual behavior as well as the decoupling of the process and product. To our knowledge, no existing simulator nor underlying simulation model provide a means to do this. To address this gap, we introduce a process simulation reference model that provides the constructs and relationships for capturing the interactions among the individuals, product, process, and project in a holistic fashion---a necessary first step towards an agile-process evaluation environment.
{"title":"A reference model for simulating agile processes","authors":"I. D. Silva, Sanjai Rayadurgam, M. Heimdahl","doi":"10.1145/2785592.2785615","DOIUrl":"https://doi.org/10.1145/2785592.2785615","url":null,"abstract":"Agile development processes are popular when attempting to respond to changing requirements in a controlled manner; however, selecting an ill-suited process may increase project costs and risk. Before adopting a seemingly promising agile approach, we desire to evaluate the approach's applicability in the context of the specific product, organization, and staff. Simulation provides a means to do this. However, in order to simulate agile processes we require both the ability to model individual behavior as well as the decoupling of the process and product. To our knowledge, no existing simulator nor underlying simulation model provide a means to do this. To address this gap, we introduce a process simulation reference model that provides the constructs and relationships for capturing the interactions among the individuals, product, process, and project in a holistic fashion---a necessary first step towards an agile-process evaluation environment.","PeriodicalId":415950,"journal":{"name":"Proceedings of the 2015 International Conference on Software and System Process","volume":"166 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2015-08-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132858497","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Companies define software processes for planning and guiding projects. Since process definition is expensive, and in practice, no one process "fits all" projects, the current trend is to define a Software Process Line (SPrL): a base process that represents the common process elements, along with its potential variability. Specifying a SPrL is more expensive than just specifying one process, but the SPrL can be adapted to specific project contexts, minimizing the amount of extra work carried out by employees. Mining project logs has proven to be a promising approach for discovering the process that is applied in practice. However, considering all the possible variations that may be logged, the mined process may be overly complex. Some algorithms deal with this by filtering infrequent relations between log events, but they may discard relevant relations. In this paper we propose the v-algorithm that uses two thresholds to set up a SPrL: highly frequent relations are used to build the base process, variable relations define process variability, and rare relations are discarded as noise. We applied the $v$-$algorithm$ to the project log of Mobius, a small Chilean software company. We obtained a SPrL where we identified unexpected alternative ways of performing certain activities, as well as an optional activity that was originally specified as mandatory.
{"title":"Software process line discovery","authors":"F. Blum, J. Simmonds, M. Bastarrica","doi":"10.1145/2785592.2785605","DOIUrl":"https://doi.org/10.1145/2785592.2785605","url":null,"abstract":"Companies define software processes for planning and guiding projects. Since process definition is expensive, and in practice, no one process \"fits all\" projects, the current trend is to define a Software Process Line (SPrL): a base process that represents the common process elements, along with its potential variability. Specifying a SPrL is more expensive than just specifying one process, but the SPrL can be adapted to specific project contexts, minimizing the amount of extra work carried out by employees. Mining project logs has proven to be a promising approach for discovering the process that is applied in practice. However, considering all the possible variations that may be logged, the mined process may be overly complex. Some algorithms deal with this by filtering infrequent relations between log events, but they may discard relevant relations. In this paper we propose the v-algorithm that uses two thresholds to set up a SPrL: highly frequent relations are used to build the base process, variable relations define process variability, and rare relations are discarded as noise. We applied the $v$-$algorithm$ to the project log of Mobius, a small Chilean software company. We obtained a SPrL where we identified unexpected alternative ways of performing certain activities, as well as an optional activity that was originally specified as mandatory.","PeriodicalId":415950,"journal":{"name":"Proceedings of the 2015 International Conference on Software and System Process","volume":"26 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2015-08-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127780827","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Improving business processes is on top of the agenda for chief and senior executives. This requires a solid understanding of current and future business processes and their alignment with the strategic objectives of the organization. Business Process Management (BPM) is an integrated set of principles, methods and tools to manage business processes with the ultimate goal of improving them. The demand for BPM is driven by the need for increased operational excellence and cost-effective compliance practices. BPM forms a widely recognized foundation for IT projects and is a key issue in discussions related to outsourcing and mergers. Not surprisingly, global analyst firms have identified BPM as the number one priority of CIOs for a number of years. This tutorial discusses the strategic skills required for leading BPM initiatives within organizations. Participants will learn the principles underlying BPM and apply these to develop a strategy for implementing and running BPM projects, and assessing their progress. Further, they will learn how to secure support for BPM and dissolve resistance within the organization. The content will be illustrated through the use of several case studies.
{"title":"Strategic business process management","authors":"Marcello La Rosa","doi":"10.1145/2785592.2785620","DOIUrl":"https://doi.org/10.1145/2785592.2785620","url":null,"abstract":"Improving business processes is on top of the agenda for chief and senior executives. This requires a solid understanding of current and future business processes and their alignment with the strategic objectives of the organization. Business Process Management (BPM) is an integrated set of principles, methods and tools to manage business processes with the ultimate goal of improving them. The demand for BPM is driven by the need for increased operational excellence and cost-effective compliance practices. BPM forms a widely recognized foundation for IT projects and is a key issue in discussions related to outsourcing and mergers. Not surprisingly, global analyst firms have identified BPM as the number one priority of CIOs for a number of years. This tutorial discusses the strategic skills required for leading BPM initiatives within organizations. Participants will learn the principles underlying BPM and apply these to develop a strategy for implementing and running BPM projects, and assessing their progress. Further, they will learn how to secure support for BPM and dissolve resistance within the organization. The content will be illustrated through the use of several case studies.","PeriodicalId":415950,"journal":{"name":"Proceedings of the 2015 International Conference on Software and System Process","volume":"38 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2015-08-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"124932818","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Open innovation is the collective term describing business collaboration which combines internal and external ideas into architectures and systems. Despite the wide interest in several domains and the unquestionable potential that open innovation can bring to the software industry, open innovation remains greatly unexplored in the software engineering literature. While the business view of open innovation proved to be beneficial, the software engineering community needs support in understanding what tools, techniques and methods are well suited or can enable open innovation on both strategic and operational levels of software engineering. OISE 2015 is the first step toward raising awareness about open innovation in software engineering academic and industrial communities.
{"title":"Summary of the 1st international workshop on open innovation in software engineering (OISE 2015)","authors":"Maleknaz Nayebi, K. Wnuk","doi":"10.1145/2785592.2785624","DOIUrl":"https://doi.org/10.1145/2785592.2785624","url":null,"abstract":"Open innovation is the collective term describing business collaboration which combines internal and external ideas into architectures and systems. Despite the wide interest in several domains and the unquestionable potential that open innovation can bring to the software industry, open innovation remains greatly unexplored in the software engineering literature. While the business view of open innovation proved to be beneficial, the software engineering community needs support in understanding what tools, techniques and methods are well suited or can enable open innovation on both strategic and operational levels of software engineering. OISE 2015 is the first step toward raising awareness about open innovation in software engineering academic and industrial communities.","PeriodicalId":415950,"journal":{"name":"Proceedings of the 2015 International Conference on Software and System Process","volume":"27 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2015-08-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115124629","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Philipp Diebold, Daniel Méndez Fernández, Darja Šmite
Agile software development has become well known to the community and is nowadays frequently used for the development of different kinds of software systems. Agile methods are widely spread and often adapted to the context-specific needs. The adaptations constitute reductions and/or extensions of agile practices. Yet, we have limited knowledge about the impact of some of the individual practices, which is crucial to justify organizational changes. To systemize the knowledge of the impact of agile practices, we launch this workshop and invite researchers and practitioners to work on a documenting and accumulating their experiences in a knowledge base.
{"title":"Summary of the 1st international workshop on impact of agile practices (ImpAct 2015)","authors":"Philipp Diebold, Daniel Méndez Fernández, Darja Šmite","doi":"10.1145/2785592.2785622","DOIUrl":"https://doi.org/10.1145/2785592.2785622","url":null,"abstract":"Agile software development has become well known to the community and is nowadays frequently used for the development of different kinds of software systems. Agile methods are widely spread and often adapted to the context-specific needs. The adaptations constitute reductions and/or extensions of agile practices. Yet, we have limited knowledge about the impact of some of the individual practices, which is crucial to justify organizational changes. To systemize the knowledge of the impact of agile practices, we launch this workshop and invite researchers and practitioners to work on a documenting and accumulating their experiences in a knowledge base.","PeriodicalId":415950,"journal":{"name":"Proceedings of the 2015 International Conference on Software and System Process","volume":"10 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2015-08-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129831791","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Choosing an appropriate software development process is a complex and challenging task, exacerbated by the fact that 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. This position paper proposes that one of the potentially most significant factors impacting how a team should structure their software development process is domain (contexts defined by the nature of the relationship between cause and effect) the team is in, an approach pioneered by Snowden with The Cynefin Framework. Cynefin (pronounced Ku-nev-in) is a decision framework that recognizes the causal differences that exist between different types of systems and proposes new approaches to decision making in complex social environments and new mechanisms of understanding levels of complexity as decisions are made. It is argued that using the Cynefin framework for classifying important software process selection decisions assists in choosing the right process for the given situational context. This position paper provides an overview of systems thinking and the Cynefin framework that organizations can use to detect the significant characteristics of the domain in which they operate which has a direct and significant affect on the software process approach (model / methodology) chosen.
{"title":"Exploring the use of the cynefin framework to inform software development approach decisions","authors":"Rory V. O'Connor, Marion Lepmets","doi":"10.1145/2785592.2785608","DOIUrl":"https://doi.org/10.1145/2785592.2785608","url":null,"abstract":"Choosing an appropriate software development process is a complex and challenging task, exacerbated by the fact that 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. This position paper proposes that one of the potentially most significant factors impacting how a team should structure their software development process is domain (contexts defined by the nature of the relationship between cause and effect) the team is in, an approach pioneered by Snowden with The Cynefin Framework. Cynefin (pronounced Ku-nev-in) is a decision framework that recognizes the causal differences that exist between different types of systems and proposes new approaches to decision making in complex social environments and new mechanisms of understanding levels of complexity as decisions are made. It is argued that using the Cynefin framework for classifying important software process selection decisions assists in choosing the right process for the given situational context. This position paper provides an overview of systems thinking and the Cynefin framework that organizations can use to detect the significant characteristics of the domain in which they operate which has a direct and significant affect on the software process approach (model / methodology) chosen.","PeriodicalId":415950,"journal":{"name":"Proceedings of the 2015 International Conference on Software and System Process","volume":"27 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2015-08-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115989686","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
J. Cadavid, Mauricio Alférez, S. Gérard, Patrick Tessier
Manufacturing processes are undergoing major challenges to achieve the Smart Factory vision such as to increase systematic processes reuse and improve understandability of complex structures. However, those challenges recall closely those of software processes which have been successfully targeted by model-driven engineering techniques such as domain-specific modeling languages, modeling abstractions based on view-points, model-based formal analysis and automated model transformations. The goal of this paper is to present a research agenda to integrate those techniques in manufacturing processes to achieve the Smart Factory vision. We first survey manufacturing approaches that are based on the ISA-95 and BPMN standards. Then, we propose model-driven solutions to complement those approaches.
{"title":"Conceiving the model-driven smart factory","authors":"J. Cadavid, Mauricio Alférez, S. Gérard, Patrick Tessier","doi":"10.1145/2785592.2785602","DOIUrl":"https://doi.org/10.1145/2785592.2785602","url":null,"abstract":"Manufacturing processes are undergoing major challenges to achieve the Smart Factory vision such as to increase systematic processes reuse and improve understandability of complex structures. However, those challenges recall closely those of software processes which have been successfully targeted by model-driven engineering techniques such as domain-specific modeling languages, modeling abstractions based on view-points, model-based formal analysis and automated model transformations. The goal of this paper is to present a research agenda to integrate those techniques in manufacturing processes to achieve the Smart Factory vision. We first survey manufacturing approaches that are based on the ISA-95 and BPMN standards. Then, we propose model-driven solutions to complement those approaches.","PeriodicalId":415950,"journal":{"name":"Proceedings of the 2015 International Conference on Software and System Process","volume":"50 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2015-08-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128795981","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
京公网安备 11010802042870号
京ICP备2023020795号-1
扫码关注我们
求助内容：
应助结果提醒方式：