Quality Risk Management Research Articles

How to Select the Best Risk Management Techniques for Different Projects

From its inception, project management has received a lot of attention from companies. Researchers have found that risk management has an important impact on project management, however, the current scope of risk management research is relatively narrow, and there are still research gaps for the various risks encountered in projects. Therefore, the research theme of this paper is to study the risk management approach to various risks. The research methodology of this paper is as follows: first, we collect data on the impact of risks on the project, then we analyze the data and propose solutions. This paper identifies three possible risks in projects and finds ways to address them. The first is a high-cost risk, for which this paper proposes three solutions. The second is the risk of quality, which can be eliminated by quality risk management. The third is the risk of schedule. The manager should redesign the project duration. This paper provides a new way of thinking that will help future researchers broaden the scope of their research.

Chemometry and Green Chemistry-Based Chromatographic Analysis of Azilsartan Medoxomil, Cilnidipine and Chlorthalidone in Human Plasma Using Analytical Quality by Design Approach.

According to the green chemistry approach, the usage of carcinogenic and teratogenic organic solvents should be minimized in the development of the analytical method for the safety of the environment and analysts. According to the literature review, no high-performance thin-layer chromatographic (HPTLC) method has been reported yet for concomitant analysis of azilsartan medoxomil (AZM), chlorthalidone (CTD) and cilnidipine (CDP) in human plasma. Hence, a robust and accurate HPTLC method has been developed using safe and non-toxic organic solvents for the concomitant analysis of AZM, CTD and CDP in human plasma, fixed-dose combinations (FDCs) and laboratory mixtures. The HPTLC method was developed by the implementation of the analytical quality by design approach using principles of quality risk management and design of experiments (DoE) for regulatory compliance. The principal component analysis was applied for the risk assessment and analysis of potential method variables in the method development. The principle of DoE was used for the response surface modeling to link identified critical method risk parameters with critical method performance attributes using full factorial design (FFD). The method operable design region and analytical control space were navigated for the optimization of the method as per quality target analytical profile. The developed method was also applied for concomitant analysis of AZM, CTD and CDP in their FDCs and laboratory mixture and results were found in good agreement with the labeled amount of the respective drug.

Quality Risk Management in Pharmaceutical Manufacturing Operations: Case Study for Sterile Product Filling and Final Product Handling Stage

In the highly regulated pharmaceutical industry, significant risks to products/processes must be formally identified, reduced, and controlled to minimize potential negative impacts on patients. Failure Modes and Effects Analysis (FMEA) is one of the well-recognized risk-management tools which is effectively used by the pharmaceutical industry to document and communicate risk control. International Conference on Harmonization (ICH) guideline Q9, Quality Risk Management (QRM), represents the first internationally recognized guideline specifically addressing QRM for the pharmaceutical and biopharmaceutical industries. However, Q9 does not provide details on how to use FMEA in real-world pharmaceutical situations. Authors have previously presented a real case study through which various risks were identified and controlled in an early stage of sterile manufacturing process, including (i) procurement/supply chain, (ii) logistics/warehousing, and (iii) raw materials dispensing. This study represents a modeled risk mitigation approach for professionals or regulators in the industry field associated with sterile pharmaceutical production processes such as (a) glass bottle washing and handling, (b) rubber stopper washing and handling, (c) product filling process, (d) final product receiving and handling. The benefits of this case study include providing a proactive means to identify, control, and communicate risks associated with various vital steps, thereby improving decision making and reducing regulatory non-compliant risk. In this study the outcomes of risk assessments associated with every defined step highlighted all critical hazards with risk priority number (RPN) scores equals to or above 105. These hazards are given the priority to be treated and put under control to reduce the RPN to acceptable levels. Although every manufacturer’s product and process are unique, and risk tolerance varies among manufacturers, some processes are generic in nature, and the associated risks are similar. Therefore, our case studies and examples can fit every circumstance in pharmaceutical manufacturing.

Risk Assessment for a Twin-Screw Granulation Process Using a Supervised Physics-Constrained Auto-encoder and Support Vector Machine Framework.

Quality risk management is an important task when it pertains to the pharmaceutical industry, as this is directly related to product performance. With the ICH Q9 guidelines, several regulatory bodies have encouraged the pharmaceutical industry to implement risk management plans using scientific and systemic approaches such as quality-by-design to asses product quality. However, the implementation of such methods has been challenging as assessment of risks requires accurate quantitative models to predict changes in quality when variations occur. This study describes a framework that quantitatively assesses risk for a twin screw wet granulation process. This framework consists of a physics-constrained autoencoder system, whose outputs are constrained using physics-based boundary conditions. The latent variables obtained from the auto-encoder are used in a support vector machine-based classifier to understand the granule growth behavior occurring within the system. This framework is able to predict the process outcomes with 86% accuracy and classify the granule growth regimes with a true positive rate of 0.73. Based on the classification the risk associated with the process can be estimated.

Management of Unplanned Changes in Production Processes: AI Control Systems

Quality risk management in industrial plants involves big calculations, the scale of which is often not only incomprehensible but also difficult to manage due to many parameters that affect the quality of production. Unsurprisingly, artificial intelligence-based quality management models are being introduced in manufacturing, only in niche, narrow areas, mostly for tracking product defects or identifying local quality defects. However, detecting the defect stage already is a late stage of the problem, which is almost always associated with a loss. Here comes the importance of prediction of problems or identifying of problematic patterns at an early stage before having production losses. Such attempts are rare and require a special approach. This type of module is needed for wide range problem forecasting in manufacturing. It should be configurable and clear not only by narrow area professionals, but also by medium-sized factory technologists who can configure such a system themselves to control their production quality risks. So here we are developing an approach whose strengths would be its simplicity, comprehensibility, fastness, and accessibility in its training, allowing us to understand why in one case or another the system predicts one decision or another.

Importance of quality management system in current scenario

A review was conducted by analysing many publications and they were concerned with the pharmaceutical quality directly and with the general quality practices. The content of those sources was analysed and some guidelines were identified which include WHO guidelines, FDA guidelines, EU guidelines and ICH guidelines. Upon reviewing the previously highlighted guidelines and the practices that are widely applied in the pharmaceutical industry, some topics were identified and reviewed like quality risk management, quality by design, corrective actions and preventive actions, process capability analysis, Six Sigma, process analytical technology, lean manufacturing, total quality management, out of trend, out of specification and HACCP.\

Quality Risk Management Algorithm for Cold Storage Construction Based on Bayesian Networks.

In the cold storage construction project, only by controlling the quality risk of the project can ensure that the cold storage can meet the expected use function and achieve the expected economic benefits after the completion of the cold storage. In order to effectively ensure the key pivot role of cold storage in cold chain logistics, a cold storage construction quality risk management system is constructed to identify and analyze quality risk factors from three dimensions: construction procedures, participating units, and work processes, construct a cold storage construction quality risk evaluation model based on Bayesian network, and through reverse reasoning analysis and sensitivity analysis, key quality risk factors are derived: inadequate quality assurance system, technical delivery not in place, mismatch of building materials and equipment, inadequate training of skilled workers, completion acceptance not careful or acceptance standards unreasonable, and duration not meeting the requirements. Finally, in view of the above quality risks, suggestions and measures are put forward from five aspects: man, material, machine, method, and environment.

Analysis and Strategies of Internet + Taxation Risk Management of Listed Companies in the Big Data Era From the Organizational Psychology Perspective.

The massive amount of information brought about by the era of big data has enormous potential value. In-depth discussion and analysis of solving the information asymmetry between tax collection and taxpayers are keys. This paper provides an in-depth study and analysis of the fiscal and tax intelligent risk management strategies of listed companies in the big data environment. The tax risk management of listed companies is optimized. Tax authorities should follow the development trend of big data, apply big data thinking, comprehensively excavate and utilize tax-related information, and improve the tax risk management model. At the same time, they should make full use of information technology to solve the problem of information asymmetry between tax collection and taxpayers and improve the quality and efficiency of tax risk management. The work discusses the problems of the current tax collection and management model in terms of management thinking, information collection, data analysis, legal system, and talent technology, and analyses the challenges brought by big data technology to the tax collection and management model as well as tax source management and tax informatization.

Approach of analytical quality by design and regulatory need

This paper gives idea about the Pharmaceutical Quality by Design (QbD) and describes use of Quality by Design to ensure quality of Pharmaceuticals. Quality cannot be tested into products but quality should be built in by design. The concept of QbD can be extended to analytical methods. The emphasis of AQbD approach is on understanding of the operation and the variables affecting Analytical Methods employed in product development. The variables which affect the output are identified and subjected to thorough risk assessment employing various tools and techniques discussed in the article, after which the variables are optimized. The final method is validated and a control strategy is put in place. Pharmaceutical firms increased the number of product development by using scientific tools such as QbD (Quality by Design). ICH Q11 guidelines clearly discussed QbD approach for API synthesis with examples. It is a current trend among pharmaceutical industry to implement analytical quality by design (AQbD) in method development process as a part of risk management, pharmaceutical development, and pharmaceutical quality system (ICH Q10). QbD has its perspectives to contribute the drug design, development, and manufacture of high-quality drug products.

A Review on Quality by Design Approach in Analytical Methods

Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives for a product, process understanding, and process control based on knowledge and quality risk management. All conventional methods may fail to the intended purpose during method development and validation. In a QbD approach, the impact and interactions between critical method variables are understood using a Design of Experiments (DOE) approach, which gives multivariate analysis and modeling leading to the consistent quality of drug products. QbD tools like risk assessment and design of experiments, enable better quality to be incorporated into the analytical method and facilitate prior understanding and identification of variables affecting method performance. The main objective of the present review article is to describe different steps involved in method development by the QbD approach for analytical method development. The QbD Approach for method development comprises various steps that include defining method intent, performing experimental design, evaluating experimental results, selecting proper method conditions, and performing risk assessment with changing analytical parameters and conditions for evaluation. The purpose of analytical QbD is to attain quality in measurement.
 Keywords: Quality by Design (QbD), Design of Experiments (DOE), Critical attributes

Bank ownership and governance quality in India: Evolution and detection of convergence clubs

Utilizing a novel panel dataset for the period from 2009 to 2018, this paper investigates how the corporate governance of Indian banks has evolved since the post-global crisis and identifies convergence clubs among banks in distinct ownership groups. It also presents optimal policy priorities for specific aspects of corporate governance. To assess the quality of bank corporate governance, we used a non-parametric “Benefit-of-the-Doubt” (BoD) approach to create a bank-wise composite index of corporate governance based on 48 governance norms. Empirical results have shown that while Indian banks have made remarkable progress in adhering to the mostly mandatory corporate governance norms in the past few years, but their current level of governance isn’t adequate to characterize it as a “socially-efficient” structure. A typical public bank generally prioritized maintaining adequate disclosure and transparency, by and large, while a private bank focuses more spotlight on audit function, followed by risk management and board quality. The results based on Phillips and Sul’s (2007, 2009) clustering and merging algorithms reveal two convergent clubs in the private banking segment and a sole club in the public sector banking segment.

Survey Study among Dentist in Bulgaria to Develop a Model for Risk Management in Dental Practice.

Background Quality control and risk management in the field of dental services is an important part of improving patient safety as well as that of the dentists. The introduction of a risk management model would simplify and facilitate this process. Aim The aim of the study is to gather information about the structurе and organization of work processes in Bulgarian dental practices, which will serve as a basis for building a risk management model. Material and Methods. A survey was conducted among randomly selected dental associations in Bulgaria-Plovdiv, Sofia, Varna, and Burgas through an anonymized questionnaire, containing 30 questions. The respondents meet the main criteria, namely, to be dentists and to practice in Bulgaria. The study includes demographic data, information on the attitude of Bulgarian dentists towards issues related to quality management, and safety and risk in respect to dental practice. The results have been processed and analyzed through descriptive and graphical analysis using the statistical program SPSS 20.0. Results A total of 103 Bulgarian dentists took part in the study, out of which 25.24% ± 4.28% have acquired a specialty. Women are 52.43% ± 4.92%, and men −47.57% ± 4.92%. The largest is the relative share of the respondents in the age range of 25-35 years −63.10% ± 4.75% and with work experience of 6-15 years −52.43% ± 4.92%. Most of the respondents do not define in writing the main tasks and activities −52.43% ± 4.92%, and do not use checklists in their practice -54.73%. The majority of the respondents do not hold regular meetings with their teams −50.49% ± 4.93%, as well as they do not conduct surveys among their patients −68.93% ± 4.56%. The majority of the respondents −41.75% ± 4.86% are guided by their personal judgment in respect to whether the written information provided to patients is comprehensible and accessible. The majority of dentists −45.63% ± 4.91% take informed consent only for expensive procedures in written and oral form −53.40% ± 4.92%. Out of all the respondents, 75.73% ± 4.22% have not analyzed the risk of slipping in their practices for the last two years. Conclusion There is a lack of written definition of the main tasks and processes, as well as no use of checklists in the practices of most of the interviewed dentists. Meetings with teams are held irregularly. There is a lack of surveys among patients, as well as no objective feedback from patients regarding the comprehensibility of the information materials provided. Informed consent is obtained from patients mainly in written and oral form and only for costly manipulations. In the practices of most of the interviewed dentists, there has been no assessment of the risk of slipping and falling for the last 2 years.

Analytical quality by design based on design space in reversed-phase-high performance liquid chromatography analysis for simultaneous estimation of metformin, linagliptin and empagliflozin.

Employing the Quality by Design paradigm through this work helped conclude the method operable design region for optimizing the high performance liquid chromatography (HPLC) assay using Design of Experiments and response surface methodology to obtain a good resolution and determination of all analysed compounds and to achieve a suitable analysis time. A deep understanding of the quality target product profile, analytical target profile and risk assessment for parameters that affect the method performance led to developing an accurate, precise and cost-effective method. Quality risk management principles were applied for determining the critical method parameters affecting the simultaneous determination of metformin hydrochloride (MET), linagliptin (LIN) and empagliflozin (EMP) by reversed-phase HPLC . The ternary mixture was successfully resolved in 5 min with a linearity range of (0.1–600) µg ml−1 for MET and (0.05–50) µg ml−1 for LIN and EMP. The newly developed method was validated according to the International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use guidelines. Good agreement was observed with the assay results of the reported UPLC one. To evaluate the greenness of the proposed method, an analytical Eco-Scale method was used.

Quality-by-Design Principles Applied to the Establishment of a Pharmaceutical Quality Control Laboratory in a Resource-Limited Setting: The Lab Water.

Quality-by-design (QbD) is defined as a systematic approach to design and develop a product/service based on sound science and quality risk management. It is already frequently applied in the pharmaceutical industry mainly in the development of pharmaceutical products and analytical methods but is not well established in the setup of facilities like quality control (QC) laboratory (lab). Therefore, lab QbD (lQbD) concept is introduced considering lab water purification system as an example. The water purification system comprising distillation unit coupled with Nanopure Analytical Ultrapure Water System combined with a 0.2-micron filter was established in Jimma University Laboratory of Drug Quality (JuLaDQ). The consistent capability of the established water purification system was evaluated through routine monitoring of the critical quality parameters (i.e., physicochemical, HPLC-DAD chromatogram total peak area, and resistivity) of freshly prepared lab water for a period of one year. In addition, quality of different grade water (tap water, distilled water (before and/or after cleaning distillation unit), and fresh ultrapure water (18.2 MΩ × cm at 25°C)) used in JuLaDQ was evaluated. The results of routine analysis of water quality revealed that HPLC global peak area at 210 and 254 nm could serve as one of the discriminatory control strategies to evaluate the capability of water purification system to produce the desired quality of lab water; and thus, we proposed a specification limit of 5,000 mAU∗s and 5,500 mAU∗s for global peak area at 254 and 210 nm, respectively, as system suitability parameter.

IMPROVING THE QUALITY OF RISK MANAGEMENT AS A PREREQUISITE FOR EFFECTIVE PROVISION OF ELECTRONIC PAYMENT SERVICES

In recent years, the use of information technology in the field of financial services is expanding, which transforms the ways of their provision and consumption. FinTech is developing rapidly, forming a powerful sector of the digital economy. Much attention focuses on digitalization and the provision of electronic payment services, which is important for the development of all types of e-business. One of the main conditions for their effective provision is risk management, improving the quality of which is becoming an urgent scientific and practical task. This is the basis for the improvement of electronic payment systems and payment ecosystems in the digital environment.
 The purpose of the article is to identify areas and practical proposals for improving the quality of risk management as a prerequisite for effective provision of electronic payment services. The importance of risk management for the enterprise-provider of electronic payment services is substantiated, taking into account the basic principles of their provision and importance in the payment infrastructure. The content and direction of improving the quality of risk management, its potential in improving the efficiency of providing electronic payment services for decision-making, reducing losses, optimizing costs and ensuring stable operation of the enterprise are explained. The understanding of the essence and subject of risk management in the field of electronic payment services and its industry characteristics is specified. Characteristics and properties that indicate the quality of risk management are explained. The goals, tasks and features of risk management at the enterprise that is the provider of electronic payment services are determined. The methodological bases of risk management at the enterprise providing electronic payment services are revealed, including strategic bases, objects, principles, types, kinds, elements, approaches, key processes and methods of risk management.
 A frame that defines the stages, nature and content of risk management components is proposed, namely: risk identification; risk monitoring and control; risk analysis and assessment; development and implementation of measures in order to minimize or eliminate risks; analysis of results and evaluation of the effectiveness of risk management measures. Practical recommendations for improving each of the components have been developed. The internal and external aspects of risk management are described. The bases of formation and directions of improvement of the risk management system at the enterprise-provider of electronic payment services within the procedural, intellectual, program-technological block are determined. PayTech risk insurance is clarified. The expediency of innovations to improve RegTech in the context of risk management is substantiated.

EANM guideline on quality risk management for radiopharmaceuticals

This document is intended as a supplement to the EANM “Guidelines on current Good Radiopharmacy Practice (cGRPP)” issued by the Radiopharmacy Committee of the EANM (Gillings et al. in EJNMMI Radiopharm Chem. 6:8, 2021). The aim of the EANM Radiopharmacy Committee is to provide a document that describes how to manage risks associated with small-scale “in-house” preparation of radiopharmaceuticals, not intended for commercial purposes or distribution.

The Production of Drugs Must Correspond to the Intended Purpose

The pharmaceutical industry maintains a high standard of quality assurance in the development, production and control of drugs. The procedure for issuing a manufacturing authorization for a medicinal product ensures the compliance of medicinal products with the applicable requirements in terms of safety, quality and efficacy, which are assessed by the competent institutions. The procedure for issuing a manufacturing authorization ensures that all medicinal products that have a manufacturing authorization are manufactured/imported by manufacturers who have a manufacturing authorization and who are regularly inspected by the competent institution, applying the principle of Quality Risk Management. A manufacturing license is required for all drug manufacturers.

Building Improvement Capabilities among Healthcare Professionals at Al Wakra Hospital, Qatar

Healthcare facilities strive to offer patients with high-quality treatment that meets their expectations/desired outcomes, improves their experiences, and reduces the risk of mistakes. As a result, constant gap analysis is essential for directing quality improvement (QI) activities toward closing gaps and maintaining gains. Since March 2014, Al Wakra Hospital (AWH) has been recognized by Joint Commission International (JCI) as one of the HMC hospitals that provide high-quality general secondary care services. The triple objective framework, which directs all improvement efforts toward better health, better care, and better value, is based on AWH strategic priorities drawn from QNHS II and the HMC strategic plan. AWH conducted a comprehensive quality and patient safety (QPS) training program aimed at enhancing staff capabilities by providing them with QPS-related knowledge, improving their skills in Quality Improvement (QI), risk management fields, JCI hospital standards, and applying what they learned to improve their processes. The QPS training program is a year-long study with a target population of all HCPs who have worked in AWH for at least 6 months. A sample of 50 participants was agreed upon, with one HCP per department. QPS training consists of three in-person modules: Quality Improvement, Risk Management (RM), and JCI. Each module includes PowerPoint presentations, questions during the session, practice and criticism activities, and a closing reflection. The participants had to be able to attend all of the training days, pass the multiple-choice questions (MCQ) post-test with a score of at least 80%, and participate in and present a QI project poster where they put what they learned in the training into practice. The scientific substance of the AWH QPS training was accredited by QCHP and The American Nurses Credentialing Center (ANCC), and members of the organizing committee and presenters signed a conflict of interest waiver. Three full days of QI module were performed on April 28th-30th, 2019, two full days of RM module were conducted on September 18th-19th, 2019, and JCI module and QI souq was conducted on December 10th, 2019. Because most of the potential participants are nurses (80% = 36 out of 45), and nurses constitute the biggest number of HCPs at AWH, the Qatar Council for Healthcare Professions (QCHP) and (ANCC) accredited the AWH QPS program in consultation with nurse planners. Nurse planners appreciate cooperatives that allow them to engage non-nurse participants in the planning process and award CPD points accordingly. As QPS-related educational and training initiatives, target all HCPs at the facility, it necessitates the use of specialized accreditor/planner agencies. AWH’s comprehensive QPS training program has emphatically affected our facility's quality and quiet security measurements and has great notoriety among the official, senior pioneers, and center administration pioneers.

The national culture as a determinant of ERM quality: Empirical evidence in the European banking context

This paper aims to investigate whether and how enterprise risk management (ERM) quality may be influenced by national culture. Using a sample of 105 banks from 21 countries over the period of 2013-2020, we document that power distance, masculinity, uncertainty avoidance and long-term orientation are significantly associated with ERM quality. Our research contributes to the existing risk literature by highlighting how the dimensions of national culture impact ERM quality. The article also discusses how the cultural dimensions of a national culture embedded in the organizational values can influence the quality of bank's risk management processes. This study helps banking regulators by providing a clear picture of how an informal institution, such as national culture, contributes to explaining differences in the quality of ERM implementation.

Supply Chain Resilience in VUCA World: Towards a Holistic Approach of Quality Assurance and Risk Management

Supply chain management is often associated with disruptions and chaos. This paper intends to explore the factors causing supply chain disruptions and develop a framework for supply chain resilience, thereby highlighting the significance of integrating quality assurance and risk management. With the help of in-depth interviews of management officials involved in the pharmaceutical supply chains in Pakistan, the study finds that a holistic approach towards quality assurance function is indispensable in the supply chain of pharmaceuticals. Drawing on the theoretical framework of chaos theory and complexity theory, the results of this study show that supply chain resilience can be achieved effectively by implementing a proper risk management system identifying the possibilities, and quantifying and mitigating the risks before they emerge. The study also highlights the differences between the supply chain resilience capability of large and small-scale pharmaceutical firms in Pakistan