Collective Intelligence-Based Quality Assurance: Combining Inspection and Risk Assessment to Support Process Improvement in Multi-Disciplinary Engineering

Abstract Background The European Medicines Agency Good Pharmacovigilance Practices (GVP) guidelines provide a framework for pharmacovigilance (PV) audits, including limited guidance on risk assessment methods. Quality assurance (QA) teams of large and medium sized pharmaceutical companies generally conduct annual risk assessments of the PV system, based on retrospective review of data and pre-defined impact factors to plan for PV audits which require a high volume of manual work and resources. In addition, for companies of this size, auditing the entire “universe” of individual entities on an annual basis is generally prohibitive due to sheer volume. A risk assessment approach that enables efficient, temporal, and targeted PV audits is not currently available. Methods In this project, we developed a statistical model to enable holistic and efficient risk assessment of certain aspects of the PV system. We used findings from a curated data set from Roche operational and quality assurance PV data, covering a span of over 8 years (2011–2019) and we modeled the risk with a logistic regression on quality PV risk indicators defined as data stream statistics over sliding windows. Results We produced a model for each PV impact factor (e.g. 'Compliance to Individual Case Safety Report') for which we had enough features. For PV impact factors where modeling was not feasible, we used descriptive statistics. All the outputs were consolidated and displayed in a QA dashboard built on Spotfire®. Conclusion The model has been deployed as a quality decisioning tool available to Roche Quality professionals. It is used, for example, to inform the decision on which affiliates (i.e. pharmaceutical company commercial entities) undergo audit for PV activities. The model will be continuously monitored and fine-tuned to ensure its reliability.

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Study on Management of Software Engineering Capability in Japan through Cross-Section Analysis and Panel Analysis

Advanced Materials Research ◽

10.4028/www.scientific.net/amr.601.576 ◽

2012 ◽

Vol 601 ◽

pp. 576-583

Author(s):

Kadono Yasuo

Keyword(s):

Quality Assurance ◽

Project Management ◽

Software Engineering ◽

Research And Development ◽

Human Resource Development ◽

Cross Section ◽

Process Improvement ◽

Panel Analysis ◽

Management Quality ◽

Section Analysis

Surveys on software engineering excellence (SEE) were designed and administrated in 2005, 2006, and 2007 in conjunction with the Japanese Ministry of Economy, Trade and Industry. In the survey, the software engineering capability was measured from the seven viewpoints of deliverables, project management, quality assurance, process improvement, research and development, human development, and customer contacts. In the present paper, we present the results of a cross-section analysis and a panel analysis. Through a cross-section analysis of the SEE data, we found superior deliverables and business performance to be significantly correlated with the effort expended on human resource development, quality assurance, research and development, and process improvement. For the panel analysis, we integrated 233 valid responses for the three years into a new database and identified 151 unique IT firms. Based on the results of the panel analysis, first, most SEE factors for a particular year had significant positive influences on the same factors the following year. Second, there were three paths to improving the level of deliverables, namely, through project management, quality assurance, and research and development, in a particular year. Third, some SEE factors had a significant positive influence on different SEE factors in the following year. Finally, several negative paths were observed, which implies that the effort put into a particular factor did not pay off in the short-term.

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Qualitative Method Used in Researching the Judiciary: Quality Assurance Steps to Enhance the Validity and Reliability of the Findings

The Qualitative Report ◽

10.46743/2160-3715/2021.4319 ◽

2021 ◽

Author(s):

Cecep Mustafa

Keyword(s):

Risk Assessment ◽

Quality Assurance ◽

Focus Group ◽

Real Time ◽

Qualitative Method ◽

Validity And Reliability ◽

Drug Offenders ◽

The Real ◽

Reduce Risk ◽

Drug Sentencing

In this paper, I present a qualitative method used in researching the judiciary. This article highlights the importance of employing a number of quality assurance steps and procedures to enhance the validity and reliability of the findings. I argue that to increase safety and reduce risk, procedural risk-assessment of the study project can be useful to deal with the real time practical difficulties that emerged from the fieldwork. To develop an understanding of what judges are trying to achieve when sentencing minor drug offenders, a total of thirty-one Indonesian judges were semi-structurally interviewed. The findings highlight that my methodology evolved by working in the field. When it was clear that not all participants were willing to be recorded, I decided to take notes. Also, I decided to conduct a kind of focus group by having two judges in the room concurrently. In this regard, I captured the participant's experience without being too intrusive. This paper contributes to the study of the method. The way in which I employed a number of quality assurance steps and procedures to enhance the validity and reliability of the findings. This fastidiousness and vigilance enhance confidence that this study's findings reflect closely the reality of drug sentencing in the courts studied over the period of fieldwork.

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