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Quantitative metrics should be used as a risk management option whenever possible. This work proposes a framework for the risk quantification and the resulting risk-based design of control charts to monitor quality control points.

Two quality control models were considered for the risk quantification analysis. Estimated operating characteristic curves, expressing the defect rate (on a ppm basis) as a function of the sample size, process disturbance magnitude and process capacity, were devised to evaluate the maximum rate of defective product of the processes. The proposed framework applicability on monitoring critical control points in Hazard Analysis and Critical Control Point (HACCP) systems was further evaluated by Monte Carlo simulations.

Results demonstrate that the proposed monitoring systems can be tuned to achieve an admissible failure risk, conveniently expressed as the number of non-conforming items produced per million products, and these risks can be properly communicated. This risk-based approach can be used to validate critical control point monitoring procedures in HACCP plans. The expected rates of non-conforming items sent out to clients estimated through stochastic simulation procedures agree well with theoretical predictions.

The procedures outlined in this study may be used to establish the statistical validity of monitoring systems that uses control charts. The intrinsic risks of these control systems can be assessed and communicated properly in order to demonstrate the effectiveness of quality control procedures to auditing third parties.

This study provides advancements toward practical directives for the implementation of statistical process control in the food industry. The proposed framework allows the assessment and communication of intrinsic failure risks of quality monitoring systems. It may contribute to the establishment of risk-based thinking in the constitution of quality management systems.

The purpose of this paper is to theorize and prioritize the main categories of risk sources for the European manufacturing small- and medium-sized enterprises (SMEs) in accordance with the International Organization for Standardization (ISO) 9001:2015 requirement “risk based thinking.” Furthermore, the research analyses how these organizations intend to manage the risks and their effects.

A first exploratory interview with 28 experts from international certification bodies and manufacturing companies which revealed 11 risk sources has been performed. Then, quality managers from European manufacturing SMEs were surveyed to determine whether or not they intended to manage the risk sources suggested by the experts. A 95 percent confidence interval was performed to evaluate the range of plausible values for the population. The quality managers were also asked to comment on each category of risk source.

The research shows that the most taken into account categories of risk sources were the internal production of nonconforming products followed by poorly trained workers with a lack of skills and awareness, supplier nonconforming products and lack of risk-based assessment. The least taken into account category was nonconforming technical results in the design process. The quality managers’ qualitative comments also brought to light interesting issues which represented avenues for new research.

The limitations of this research lie in the first exploratory interview with the 28 experts. This process could be improved by means of a larger sample of experts. Furthermore, these experts could have included risk source categories which could fall outside of an ISO 9001 quality management system (QMS) scope and application.

Quality managers in SMEs can now address the new ISO 9001:2015 requirement knowing what the priorities from a statistical point of view are. This implication is also relevant to QMS consultants who are implementing ISO 9001:2015 QMS together with their customers.

The novelty of this research is that it has been tried for the first time to theorize what the main categories of risk sources in accordance with the risk-based thinking requirement are for European manufacturing SMEs.

The purpose of this paper is to explore the mediating effect of supply chain risk management integration (RMI) on the relationship between supply chain logistics performance (LP) and supply chain cost performance (CP), as well as on the relationship between LP and supply chain service performance (SP). The impact of CP and SP on overall firm performance (FP) is also explored. ISO 9001-certified firms and non-certified firms are assessed to determine whether superior risk-based thinking, as required in the latest ISO 9001 standard, has a positive impact on the different relationships.

A theoretical model is developed and tested based on the participation of 140 supply chain managers. The proposed structural equation model positively relates LP, RMI, CP and SP. RMI is positively linked to CP and SP, while CP and SP are positively related to overall FP. Two subsamples (a group of 63 ISO 9001-certified firms and a group of 77 non-certified firms) are used to evaluate the model.

For certified and non-certified firms, LP is positively related to RMI, CP and SP, and SP and CP are positively related to FP. However, for certified firms, RMI partially mediates the relationship of LP with both CP and SP, while for non-certified firms, RMI does not mediate these relationships. The findings suggest that ISO 9001-certified firms are able to leverage RMI efforts to impact positively on supply chain performance, whereas non-certified firms are not.

The study findings are based on the perceptions of managers. Even though the majority of the 63 certified firms included in this study were ISO 9001:2015 certified, the model results do not differentiate between companies certified to the 2008 version of the standard and the 2015 version (which specifically requires demonstration of risk-based thinking).

This study suggests that ISO 9001 provides a framework for risk management processes and collaboration with supply chain partners to positively impact the relationship of LP with cost and SP.

This is one of the first studies to characterize the benefits of using a structured approach for risk-based thinking that is associated with ISO 9001.

The purpose of this paper is to investigate Financial Action Task Force (FATF)'s risk‐based guidance to combat money laundering and terrorist financing to determine its approach to the identification and management of low‐risk providers, products and transactions.

The paper analyses the relevant FATF recommendations and its guidance notes and reflects on key questions for regulators and financial institutions.

FATF has not defined “risk” for purposes of the risk‐based approach. The absence of a clear definition complicates the identification of low‐risk products. FATF do provide an example of a risk matrix that can be used to identify low‐risk banks, but the example is based on assumptions and generalisations that are not sustainable. In addition, it identifies certain low‐value transactions as “low risk” transactions. The paper reflects on the role of value as an indicator of risk and concludes with a number of suggestions to clarify the conceptual framework.

Low‐risk products and transactions are often overlooked because the risk‐based approach focuses attention on high‐risk matters. Low‐risk products are however crucial to the efforts to increase financial inclusion. The paper identifies gaps in the current conceptual framework and indicates ways in which they can be addressed.

Debate is growing around the expansion of risk-based regulation. The regulation scholarship provides evidence of regulatory failure of the risk-based approach in different domains, including financial regulation. Therefore, this paper aims to provide cautionary evidence about the risk of regulatory failure of risk-based strategy in the financial regulation while using enterprise risk management (ERM) as a meta-regulatory toolkit.

Based on interview data gathered from 30 risk managers of banks and five regulatory personnel, combined with secondary data, this study mainly explores the challenges for meaningful use of ERM based self-regulation in regulated banks. The evidence helps to assess the risk of regulatory failure of the risk-based regulation while using ERM.

The evidence reflects that regulated banks face diverse challenges arising from both peripheral and internal environments that limit the true internalization of ERM-based self-regulation. Despite this, the regulator uses this self-regulation as a meta-regulatory toolkit under the risk-based regulation to achieve the regulatory aims. However, the lack of true internalization of ERM based self-regulation is likely to raise the risk of regulatory failure of risk-based regulation to achieve the regulatory goals. Risk-based regulation is an evolving strategy in the regulatory regime. Therefore, care should be taken while using ERM as a regulatory toolkit before relying on it substantially.

The paper provides empirical insights about the challenges for effective use of ERM as a meta regulatory toolkit that might be useful practically both to the regulators and regulated firms.

The purpose of this paper is to present a risk-based prioritization method (RBPM), using functional failure risk and strategic importance assessment, in order to support public managers' decision-making process for the planning and allocation of scarce resources.

The methodology incorporates two assessment matrices into a management group’s decision-making process for resource allocation. As part of an action research strategy, the authors present the developed RBPM and its application in one Norwegian police district.

The RBPM provides a processual approach to detect risk of failures in the organization, which can facilitate better planning and allocation of resources, to mitigate risks from materializing and enhance performance. The results also indicate that the proposed assessment models provide an easier approach to consolidating different perspectives and weighting the strategic importance of disciplinary functions, when prioritizing the planning and allocation of scarce resources is necessary.

The research is restricted in that it only considers one police district in Norway. Further limitation surrounds the issue of generalizability, as only one unit from the district is used. Further research should adapt and extend the developed RBPM in the district.

The RBPM may be of interest to public managers in the emergency sector operating with a large number of disciplinary functions in a highly dynamic and uncertain environment.

The RBPM applied in this study is based on approaches with advanced application in the oil and gas industry adapted to a contextually different environment which, in contrast, consists of functional hierarchies composed of human resources.

The purpose of this paper is to identify key questions that should be addressed to enable the Financial Action Task Force (FATF) to provide guidance regarding the alignment of anti‐money laundering, combating of financing of terror and financial inclusion objectives.

The paper draws on relevant research and documents of the FATF to identify questions that are relevant to consider when it formulates guidance regarding the alignment between financial integrity and financial inclusion objectives.

The FATF advises that its risk‐based approach enables countries and institutions to further financial inclusion. It is, however, not clear what the FATF means when its uses the terms “risk” and “low risk”. It is also unclear whether current proposals for financial inclusion regulatory models will necessarily limit money laundering as well as terror financing risks to levels that can be described as “low”. The FATF will need to clarify its own thinking regarding low money laundering and low terror financing risk before it will be able to provide clear guidance to national regulators and financial institutions.

This paper was drafted to inform current FATF discussions regarding guidance on financial inclusion. The questions are relevant to all stakeholders in financial regulation.

The purpose of this paper is to investigate the influence of ISO 9001 quality improvement requirements in ISO 9001:2008, i.e. the corrective and preventive actions and internal audit, on customer satisfaction.

For the purposes of the study, data were collected via a survey on 200 aerospace and transportation companies that belong to a Canadian multinational company supply chain. The relationships between the corrective and preventive actions and internal auditing, on the one hand, and customer satisfaction, on the other, were examined via the structural equation modeling technique.

The major contribution of this study is that it has identified internal audit as the most influential continual improvement ISO 9001 requirement prior to the ISO 9001 transition phase, along with the corrective actions, while the preventive actions in the present formulation do not significantly influence customer satisfaction.

This study is based on a cross-sectional survey conducted on the supply chain level in the aerospace and transportation sector; hence, a longitudinal study is possible as a future research avenue. The generalizability of this study’s findings is limited to similar supply chains around a multinational company consisted of companies that have at least ISO 9001 standard, but also fulfill other industry-specific requirements. Also, findings are based mainly on quality managers’ attitudes, so future studies are recommended to examine other positions’ views, too.

This research contributes to the literature and bridges the gap between theory and practice. It could be of value to both the certification bodies and the organizations that are interested in improving customer satisfaction by implementing ISO 9001 in the multinational supply chains context such as the aerospace and transportation sector.

While the influence of the ISO 9001 standard on customer satisfaction has been the subject of prior research, this is the first time that the simultaneous effect of the corrective and preventive actions and internal auditing on customer satisfaction has been studied. The validity of the removal of preventive actions from ISO 9001:2015 has also been analyzed.

The purpose of this paper is to develop a conceptual auditing framework (CAF), which can help the organizations that experience difficulties with current ISO 9001 auditing to achieve their desired benefits with regard to the auditing of conformance, performance, risk management and improvement collectively.

A literature review was undertaken to identify the audit limitations and the program strategies that were reported in literature to overcome these limitations. The relevant audit standard (ISO 9001:2015) and guidelines (ISO 19011:2011 and ISO 19011:2018) have also been reviewed to determine the gap in relation to this purpose.

Most of the previous suggestions to overcome the difficulties of the current ISO 9001 auditing were to focus on processes in addition to ISO 9001 clauses and to apply the two principles of “Process Approach” and “Improvement” of ISO 9001, by having the manner of integration of their risk-based thinking concept and Lean Six Sigma (LSS) approaches, respectively, within audit. However, this integration also has limitations such as the desire for implementing risk management program and the necessity for applying LSS approach. Therefore, a CAF was developed to enhance the ISO 9001 quality audit. It suggests the integration of 12 management tools that are connected to the seven principles of ISO 9001:2015 severally and collectively. The selected tools ought to be linked to the audit limitations that have been previously reported in the literature, and connected with the complaints of the organizations that experience difficulties with current ISO 9001 auditing. Auditing of conformance/performance, risk management and improvement in combination can be assured by upgrading, testing and validating this CAF.

Utilizing the ISO 9001 quality audit in a way that helps organizations to audit performance, risk management and improvement in combination by changing the auditing approach from ISO 9001 elements to ISO 9001 principles and by learning from the experience of business excellence models implementers in development of the Performance measurement frameworks and in converting the concepts and principles into practice.

This is a briefing by the author on his PD Leake lecture given at the Chartered Accountants’ hall earlier in the year. In it he examines the rise and rise of the risk industry and assesses the changes it has wrought in business life. He argues that unless the rise is halted we will see the retreat of socially valuable intelligence from the public domain.