João Barata

ISO2: A New Breath for the Joint Development of IS and ISO 9001 Management Systems

We present ISO2, an approach for the joint development of information systems (IS) and ISO 9001 quality management systems (QMS). ISO2 was outlined from 14 retrospective case studies, occurred between 2008 and 2012. We then validated and refined the approach through action research. We support the idea that IS and QMS synergies are more important than the perspective of one system merely supporting the other. The ISO2 combines iterative development steps with a layered and incremental design framework, the O2. The O2 metaphor can provide a common abstraction level for the joint design. Over one million companies struggle with IS and QMS disintegration. Our findings offer new insights for the joint development of organizational systems.

Synergies between quality management and information systems: a literature review and map for further research

We review existing work on synergies between information systems (IS) and quality management systems (QMS) and propose avenues to advance them further, leading to a whole that is greater than the sum of the two parts, moving away from current practice, where the lifecycles of IS and QMS are handled independently, by different teams, equipped with disconnected tools and methodologies. We start with a literature review that makes sense of a puzzle of 91 articles published since 1979. Three focal categories of papers are identified and discussed, namely (1) IS in support of QMS, (2) QMS in support of IS, and (3) a shared view of IS and QMS. As 80% of the papers address the limited perspective of one type of system being dominant, in the second part of the paper we propose a map for further research.

Mobile supply chain management in the Industry 4.0 era: An annotated bibliography and guide for future research

Purpose The purpose of this paper is to identify avenues for future research in mobile supply chain management (mSCM) in the advent of Industry 4.0. Design/methodology/approach A systematic literature review was used to identify, classify, and analyze current knowledge, identify trends, and propose recommendations for future research. Findings Other research fields, such as operations, production, industrial engineering, and computer science, seem to have a head start in research into Industry 4.0. Several avenues are suggested for investigation under an information systems lens. Research limitations/implications Despite the care taken in the systematic literature review, the language (English), the selected keywords, and selected databases represent a natural limitation. Practical implications With Industry 4.0 at the top of the agenda of managers and countries, it is important to identify relevant research avenues. Originality/value A gap between the extant literature on mSCM and new concerns raised by Industry 4.0 is presented, and some research opportunities to close those gaps are proposed.

MUVE IT: reduce the friction in business processes

– The purpose of this paper is to present a lightweight approach to help diagnose and eliminate issues in existing business processes, which cause participants to resist following them as modelled. The analysis is made accessible by the use of drillable graphical dashboards. , – Two action research cycles in two distinct industries were used to test and refine the approach, while also solving the specific organizational issues. , – The approach was considered simple to use and proved capable of identifying pain points causing friction in the smooth operation of business processes. Various longer-term positive effects were reported by one of the organizations that is ISO 9001-certified. , – This type of research benefits from experiments in new cases with different contexts that can challenge it. In particular, it would be interesting to evaluate the approach in an organization with a more ad hoc view of processes, as opposed to the more standards-based cases of this paper. , – Using the proposed approach to tune the processes, so that participants are more willing to follow them, removes some inconsistency of operations and potential non-conformities in audits. , – The proposed approach is aimed at the “social sustainability” of the business processes, as it seeks to eliminate people grievances with those processes and make them sustainable in the long term. , – Although there is a lot written about process improvement, the literature is scarce in lightweight, pragmatic approaches to identify and resolve the social aspects that cause participants to deviate from the processes, or see them as a burden instead of valuable help for their everyday tasks.

Digital Transformation in the Pharmaceutical Compounds Supply Chain: Design of a Service Ecosystem with E-Labeling

We propose the design of a digital service ecosystem for the pharmaceutical compounds supply chain. Our method of inquiry is the canonical action research and a retail pharmacy provides the setting. A comprehensive review of existing literature about compounding of medicines is provided and six digital services identified: Supply management, Product traceability, Quality management, Order management, Digital assistant, and Product experience. The new services are supported by dynamic QR code identification and mHealth technologies. Preliminary results suggest that the digital ecosystems offer an opportunity to implement electronic labels (e-labels) in pharmacies, improve medicine information quality, and restore a broken link between medicine customer and medicine producer. Our findings can assist service design and service innovation in pharmaceutical supply chains. Moreover, they can support retail pharmacies in dealing with the increase of medicine compounding, address regulatory pressure for e-labeling, and to take advantage of their proximity to local communities.

Mending the patchwork of requirements from multiple standards using participative goal modelling: a case in the food industry

An increasing number of concurrent standards and regulations is being imposed on organizations operating in various domains. From healthcare to automotive to food, demands from national legislation, directives of each target market, and edicts from specific clients are creating a patchwork of requirements for compliance and audit. Managing these disconnected frameworks involves considerable overhead, duplications, and conflicts. But integrating and harmonizing these requirements needs the collaboration of varied stakeholders, with different trainings and backgrounds, capable of translating the impacts of the various norms in the different sectors of the organization. We propose a participative goal-oriented approach, consisting of four steps, to assist in this process. It brings together the requirements from the various regulations, the organizational goals, and measurement indicators. We describe its use in a company operating in the food industry, one of the most regulated in the world, where audits are very frequent, to integrate ISO 22000, IFS Food, and BRC Global Standards. Our findings show that an effective integration of the multiple regulations was possible and that the resulting goal diagrams are an effective tool for communicating with various stakeholders, such as employees, clients, auditors, consultants, and representatives of industry initiatives.

Dealing with Risks and Workarounds: A Guiding Framework

We present rISk-arounD, an enterprise-wide framework for modeling risks and workarounds in conformity with ISO 9001. The mode of inquiry is the canonical action research (CAR), conducted in a metalworking company. Our contribution suggests that (1) risks and workarounds should be jointly considered to model uncertainty in organizations, (2) participative enterprise modeling can assist process improvement and regulatory compliance, and (3) it is also necessary to address informal “shadow” practices in enterprise models. Moreover, we discuss how to adopt CAR to promote a culture of participative enterprise modeling. This framework can help organizations in their transition to the new 2015 version of ISO 9001, which endorses process oriented approaches and risk-based thinking as top priorities.

Modeling the Organizational Regulatory Space: A Joint Design Approach

We present an approach for the joint design of organizational regulatory spaces (ORS). The approach was validated through action research, integrating the components of context, people, process, information, and IT. The design of the ORS is usually performed by distinct teams, with unconnected viewpoints, using different vocabularies and tools. Similarly to information systems, there are business experts that define the regulatory goals and rules. The ORS modeling is problematic, and is fragmented. We have adopted the O2 framework to provide a common level of abstraction for the design. The result is a comprehensive and layered map of the ORS. This approach has proved to offer an effective representation of the ORS for external auditors and business associations. Internally, we provide organizations with new ways to model, communicate, and improve the regulatory space.

Product Traceability in Ceramic Industry 4.0: A Design Approach and Cloud-Based MES Prototype

We propose a customer-focused approach to design product traceability for Industry 4.0. Our design-science research includes a review of traceability technologies and participative enterprise modeling in the ceramic industry. We find benefits in combining Business Process Modeling Notation and Goal-oriented Requirements Language representations to (1) promote reflection by experts with different backgrounds, (2) reach consensus with a solution that addresses the goals of multiple stakeholders, and (3) ensure that customers’ needs are a priority in traceability design. The resulting model combines technologies in different stages of the product lifecycle and is implemented in a cloud-based MES (Manufacturing Execution System) prototype. Depending on each stage and strategic intention, the identification code can be embedded in the product, transport, or package. Our contribution can assist managers in the creation of cloud-based MES to support traceability integration at (1) technological, (2) vertical, and (3) horizontal levels that are required in the fourth industrial revolution.

Repeated Mesenchymal Stromal Cell Treatment Sustainably Alleviates Machado-Joseph Disease

Machado-Joseph disease (MJD) or spinocerebellar ataxia type 3, the most common dominant spinocerebellar ataxia (SCA) worldwide, is caused by over-repetition of a CAG repeat in the ATXN3/MJD1 gene, which translates into a polyglutamine tract within the ataxin-3 protein. There is no treatment for this fatal disorder. Despite evidence of the safety and efficacy of mesenchymal stromal cells (MSCs) in delaying SCA disease progression in exploratory clinical trials, unanticipated regression of patients to the status prior to treatment makes the investigation of causes and solutions urgent and imperative. In the present study, we compared the efficacy of a single intracranial injection with repeated systemic MSC administration in alleviating the MJD phenotype of two strongly severe genetic rodent models. We found that a single MSC transplantation only produces transient effects, whereas periodic administration promotes sustained motor behavior and neuropathology alleviation, suggesting that MSC therapies should be re-designed to get sustained beneficial results in clinical practice. Furthermore, MSC promoted neuroprotection, increased the levels of GABA and glutamate, and decreased the levels of Myo-inositol, which correlated with motor improvements, indicating that these metabolites may serve as valid neurospectroscopic biomarkers of disease and treatment. This study makes important contributions to the design of new clinical approaches for MJD and other SCAs/polyglutamine disorders.