scholarly journals Managing Knowledge and Risk – A Literature Review on the Interdependency of QRM and KM as ICH Q10 Enablers

2020 ◽  
Vol 26 (4) ◽  
Author(s):  
Marty Lipa ◽  

Quality Risk Management (QRM) and Knowledge Management (KM) have been positioned as co-enablers to the Pharmaceutical Quality System since the 2010 issuance of ICH Q10. Yet these disciplines have remained largely distinct and disconnected in practice. This paper presents a two-part literature review on this topic. First is a review of how other industries have connected risk management and knowledge management. This is followed by a review of relevant biopharmaceutical industry regulatory guidance to explore expectations for how risk, risk management, knowledge and knowledge management are interdependent. The results suggest there is a strong argument in favor of linking risk management and knowledge management and other industries have demonstrated benefits in doing so. Furthermore, the review of the biopharmaceutical industry regulatory guidance shows the clear and persistent benefits of connecting the expectations of managing risk and knowledge together. A key conclusion is that risk varies inversely with knowledge application and therefore, a lower level of risk to quality (and ultimately to the patient) can be achieved through risk management practices when a thoughtful and programmatic approach to knowledge management is in place, providing the best possible knowledge to assess and control risk.

2010 ◽  
Vol 1 (1) ◽  
pp. 1 ◽  
Author(s):  
Ruth Murray-Webster ◽  
Sergio Pellegrinelli

Risk management practices as described in many leading texts feel counterintuitive to many practitioners and are frequently ignored, despite their being evidently logical and potentially valuable. Such practices are often conceived as a remedial post-planning, audit activity. This paper proposes an approach for dealing with project uncertainty and risk, grounded in economics and taking into account behavioural biases and heuristics. The proposed approach is argued to be an enhancement to conventional risk management practices and one that can serve organisations better while also aligning to experienced practitioners’ intuitive approaches. In particular, we argue: that the focus should be on adding economic value rather than reducing risk per se; that opportunity gain/loss is a superior metric for gauging potential impacts of risky events; and that creation of real options should be emphasised as part of the repertoire of generic response actions to risk. The approach also supports the integration and handling of uncertainty and risk as part of holistic project planning and control.


2020 ◽  
Vol 11 (8) ◽  
pp. 1555-1581 ◽  
Author(s):  
Adel Elgharbawy

Purpose This study aims to compare types and levels of risk and risk management practices (RMPs) including the recognition, identification, assessment, analysis, monitoring and control of risk in both Islamic and conventional banks. Design/methodology/approach A questionnaire survey was conducted among the Islamic and conventional banks in Qatar, together with an analysis of archival data extracted from the Thomson Reuters Eikon database for the period 2009-2018. Data were analysed using descriptive statistics, ANOVA and regression analysis. Findings Islamic banks encounter unique types and levels of risk that are not encountered by conventional banks. In Islamic banks, risks such as those of operation and Sharia non-compliance are perceived to be higher, while in conventional banks other risks such as those of credit and insolvency are higher; other risks, for example, liquidity risk, are faced by both. RMPs are determined by understanding risk and risk management, risk identification, risk monitoring and control and credit risk analysis, but not by risk assessment and analysis. However, the RMPs of the two types of bank are not significantly different, except in the analysis of credit risk. Research limitations/implications The study contributes to the debate in the literature by developing a better understanding of the dynamism of risk management in Qatari banks, which can be extended to similar contexts in the region. However, the relatively small sample size in only one country limits the possibility of generalizing the findings. The survey methodology is based on the perception of bankers rather than their actual actions and does not provide in-depth analysis for each type of risk, especially credit risk. However, using archival data, in addition to those from the survey, minimises the bias that would result from depending on one source of data. Practical implications The study provides valuable insights into the different types and levels of risk, as well as the RMPs in Islamic and conventional banks, which can help in guiding the future development and regulation of risk management in the banking sector of Qatar and its region. Originality/value The study helps to explain the mixed results of previous studies that compare types and levels of risk and RMPs in Islamic and conventional banks. Using different types of data and analysis, it provides evidence from one of the fastest growing economies in the world. It also addresses the concerns over RMPs in banks since the global financial crisis.


2020 ◽  
Vol 1 ◽  
pp. 657-666 ◽  
Author(s):  
J. Oehmen ◽  
A. Guenther ◽  
J. W. Herrmann ◽  
J. Schulte ◽  
P. Willumsen

AbstractThis paper reviews the literature on risk management practices and methods in product design and development. Based on an expert workshop by the Risk Management Processes and Methods in Design Special Interest Group within the Design Society and literature review, three key areas are discussed: risk identification, assessment, and mitigation. In each area, researchers have described practices that are used in product development organizations, proposed new methods to support risk management processes and decision-making, and generated evidence to evaluate the effectiveness of these activities.


Author(s):  
Fabiana Borelli Amorim ◽  
Maria Inês Tomaél

Estudos sobre gestão de conhecimento (GC) e gestão da informação (GI) vêm sendo apresentados em profusão na literatura. Diversas discussões emergem a respeito das principais divergências e convergências destes conceitos, mas na prática a distinção ainda é bastante confusa. Desta forma, a proposta deste estudo é identificar as principais características de GC e de GI, por meio da literatura e pela análise de estudos de caso de empresas brasileiras apresentados no livro Gestão do Conhecimento no Brasil, organizado por Angeloni (2008). Os resultados demonstram e exemplificam a adoção de várias práticas de gestão como: lista de discussões, universidade corporativa, compartilhamento de conhecimento e experiências, entre outras, que em alguns casos culminaram na Gestão do Conhecimento.AbstractStudies about knowledge management (KM) and information management (IM) have been presented in great quantity in the literature nowadays. There are several discussions regarding the main divergences and convergences of these concepts, but in practice the difference is still quite confused. This way, the proposal of this study is to identify the main characteristics of KM and IM, through the literature review and by analysis of compared Brazilian companies’ casse presented in the book Knowledge Management in Brazil, organized by Angeloni (2008). The results demonstrate and exemplify the adoption of several management practices like: list of discussions, corporate university, knowledge and experiences sharing, among others, that in some cases resulted in Knowledge Management.Keywords: Information management; Knowledge management; Organizational practice


2016 ◽  
Vol 6 (3) ◽  
pp. 36-44 ◽  
Author(s):  
Christo Ackermann ◽  
Ben Marx

Internal audit functions (IAFs) of organisations are regarded as crucial components of the combined assurance model, alongside the audit committee, management and external auditors. The combined assurance model aims at having integrated and aligned assurance in organisations with the overall aim of maximising risk and governance oversight and control efficiencies. In this regard, internal audit plays a crucial role, insofar as it consists of experts in risk, governance and control consultancy who provide assurance to senior management and the audit committee. Audit committees are dependent on internal audit for information and their effectiveness revolves around a strong and well-resourced internal audit function which is able to aid audit committees to meet their oversight responsibilities. There is thus a growing demand for managing risk through the process of risk management and internal audit is in a perfect position to assist with the improvement of such processes. If internal auditors wish to continue being an important aspect of the combined assurance model, they need to address the critical area, amongst others, of risk management as part of their work. If not, it follows that the board, audit committees and other levels of management will remain uninformed on the status of these matters which, in turn, will negatively impact the ability of these stakeholders to discharge their responsibilities. This study therefore focuses on analysing the functioning of IAFs, with specific reference to their risk management mandate. The study followed a mixed method approach to describe internal audits risk management functioning in the big eight metropolitan municipalities in South Africa. The results show that internal audit provide a broad scope of risk management work which assist senior management in the discharge of their responsibilities. However, in the public eye, internal audits risk management functioning is scant.


2016 ◽  
Vol 16 (1) ◽  
pp. 18-32 ◽  
Author(s):  
M.Reza Hosseini ◽  
Nicholas Chileshe ◽  
Jacqueline Jepson ◽  
Mehrdad Arashpour

A review of published studies on risk management in developing countries reveals that critical success factors for implementing risk management has remained an under-researched area of investigation. This paper is aimed at investigating the perceptions of construction professionals concerning the critical success factors (CSFs) for implementation of risk management systems (IRMS). Survey data was collected from 87 construction professionals from the Iranian construction industry as a developing country. The results indicate that four factors are regarded as highly critical: ‘support from managers’, ‘inclusion of risk management in construction education and training courses for construction practitioners’, ‘attempting to deliver projects systematically’, and ‘awareness and knowledge of the process for implementing risk management’. Assessing the associations among CSFs also highlighted the crucial role of enhancing the effectiveness of knowledge management practices in construction organisations. Study also revealed that parties involved in projects do not agree on the level of importance of CSFs for implementing risk management in developing countries. This study contributes to practice and research in several ways. For practice, it increases understanding of how closely knowledge management is associated with the implementation of risk management systems in developing countries. For research, the findings would encourage construction practitioners to support effective knowledge management as a precursor to higher levels of risk management implementation on construction projects. 


IFLA Journal ◽  
2019 ◽  
Vol 45 (4) ◽  
pp. 309-321
Author(s):  
Saima Kanwal ◽  
Miguel Baptista Nunes ◽  
Muhammad Arif

The investigation reported in this paper intended to explore the research on knowledge management in higher educational institutions in South Asian countries. A systematic literature review was conducted to identify, select and retrieve relevant scholarly literature, by following a detailed protocol and a systematic data extraction strategy. The findings of the study showed that limited research on knowledge management in the context of higher educational institutions was conducted in both theoretical aspects and practical implementations, denoting an imperative to conduct more research in this area. The findings also disclosed that multiple factors affect the knowledge management practices among primary higher educational institution agents: faculty, administrative staff, and information professionals. As the result of the analysis of the literature review findings, a conceptual framework is proposed, which is expected to provide a good foundation for future research as well as pave the way towards more successful knowledge management implementations in the higher educational institutions in South Asia and beyond.


2014 ◽  
Vol 18 (4) ◽  
pp. 777-794 ◽  
Author(s):  
Ram Manohar Singh ◽  
Meenakshi Gupta

Purpose – This paper aims to develop a scale to measure knowledge management holistically at team level and to provide an empirical integration to a fractured body of literature on knowledge management. Design/methodology/approach – Ten concepts commonly studied under the umbrella term “knowledge management” were reviewed. On the basis of literature review, a semi-structured interview was conducted with 24 information technology (IT) professionals. A scale was developed based on the literature review and the interviews. The scale was tested in two phases, on samples of 91 and 699 IT professionals. Team knowledge management was analysed on 512 respondents, belonging to 34 teams. Findings – Findings suggest that the newly developed scale is a reliable and valid measure of knowledge management. Exploratory factor analysis of the 27-item scale suggests that knowledge management should be measured along four dimensions: knowledge creation, sharing, retention and actionable knowledge support. Practical implications – Organizations expect their teams to make the best use of knowledge resources. This scale would help organizations diagnose knowledge management practices in teams and develop interventions according to the needs of each team. The scale and four-factor model will provide a framework and a tool to investigate relationship of knowledge management with other variables. Originality/value – The attempts to integrate literature on knowledge management have largely been theoretical, and there has been little empirical work to provide an integrative framework for knowledge management concepts. This paper presents an empirical basis for the integration of knowledge management concepts. The paper also presents development of a scale which measures knowledge management practices in teams.


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