Effective Quality Management System Research Articles

A retrospective regulatory analysis of FDA recalls carried out by pharmaceutical companies from 2012 to 2023

To introduce products in the US market, pharmaceutical companies must first obtain FDA clearance. Manufacturers might recall a product if it poses a risk of damage or violates FDA regulations. This study investigates the types, causes and consequences of recalls, as well as FDA participation and suitable recall strategies. We relied on the FDA website to gather recall data sets from 2012 to 2023, collecting information on the date of issuance, company and type of violation. The most frequent causes for recalls were sterility issues and inadequate compliance with current good manufacturing practices (cGMP). An examination of sterility recalls revealed two primary causes: a lack of assurance in sterility (accounting for 48% of recalls) and instances of non-sterility (making up 45% of recalls). A thorough examination of cGMP recalls revealed five primary types of violations: process control issues, inadequate storage practices, manufacturing problems, the presence of nitroso-amine impurities and concerns regarding stability. The findings demonstrate that sterility and cGMP compliance are FDA priorities. Pharmaceutical companies must, therefore, enhance quality compliance and create effective quality management systems that oversee the manufacturing process, quality control, personnel training and documentation to avoid these recalls. Companies should establish an internal compliance checklist and be prepared for the rectification process.

University of Rizal System’s Quality Management System Toward Sustainability Framework

A quality management system (QMS) is considered key to the sustainable development of any institution. Its proper implementation is crucial in planning, implementation, assessment, and development and control of changes in the processes and procedures of the university. This study sought to assess the QMS implementation of the University of Rizal System based on ISO 9001:2015 standard and ultimately propose a sustainable framework based on the data obtained from the selected stakeholders of the university and evaluation results of the certifying body. A mixed method of research employing a sequential explanatory approach was utilized to adequately gather and analyze quantitative data using survey questionnaires and qualitative data through document analysis. Findings revealed that the University of Rizal System has manifested a functional, efficient, and effective quality management system necessary for the delivery of products and services to ensure stakeholders’ satisfaction with their needs and interests. The quality management system of the university has established and maintained an effective system to ensure compliance with its policy and objectives, that is, the organization’s management system complies with, adequately maintains, and implements the requirements of the ISO 9001:2015 standard. However, while the quality management system of the University remains effective, efficient, and compliant with the standard, improvement in its implementation is inevitable particularly in the control of the operation of processes, monitoring and attending to nonconformities and corrective actions, and on needed support to implement QMS. Hence, a proposed sustainability framework is highly recommended. Keywords: Quality Management System, Sustainability Framework, Sequential Explanatory Approach, University of Rizal System – Philippines

ТЕОРЕТИЧНІ ОСНОВИ ФОРМУВАННЯ СИСТЕМИ УПРАВЛІННЯ ЯКІСТЮ НА ПІДПРИЄМСТВІ

Creating an effective quality management system is important because it leads to the efficient and successful operation of enterprises in competitive environments. The purpose of the article is to analyze and substantiate the theoretical foundations for forming a quality management system in an enterprise. The research process utilized methods of a systemic approach to clarify the economic essence of the concept of "quality"; historical-economic analysis to examine the stages of quality system formation; methods of information processing; and monographic study when exploring issues related to the implementation of management systems at enterprises. The article discusses the scientific-theoretical aspects of quality management systems in enterprises. The necessity of continually improving product quality and forming quality management systems in enterprises has been identified. The theoretical basis of the concept of "quality" was investigated. The evolution of perspectives on the concept of quality was examined. The analysis revealed that there is no single definition of the essence of quality. Different sources provide different formulations of the "quality" category. The positive impact on enterprise operations due to the implementation of quality management systems was noted. The principles of management on which systemic quality management is based and the stages of quality system formation were discussed. The ISO 9000 series standards system, national standards, and the emphasis on the use of integrated quality management systems were characterized. It was concluded that the implementation of quality management systems in enterprises positively affects their activities, providing advantages, primarily in improving managerial and production decision-making, helping to create a management tool for the enterprise that enhances its competitiveness and ensures continuous development. According to the requirements of international ISO 9000 series standards, the effectiveness of activity in the quality system is assessed by the ability of the enterprise to prevent possible non-conformities.

Meritocracy and certification in the quality of public managemen

This research is nuanced and directed to the study and incorporation of the quality of officials in government and public management. It is clear to optimize that this study of the most representative literary contributions, shared and disseminated in recent years. They approach the various global changes of social impacts and their influence on the transformations of public policies and improvement of state entities. Share an approach to modernity and new governance based on qualified and expert staff. Together with a legal framework, which raises a vision between a new public management and quality of professionals based on their experience and professional technical capacity that from the sampling and administrative reforms applied in the magnitude of the extension of Latin American governments in recent years and international organizations, public and private within a policy of implementation and operation of effective quality management systems. The quality management models and the certification of services under international quality and capacity standards such as ISO 9000 and the analysis of processes supporting public management are definitely taken as a premise

Quality management in educational organizations: transformation of the environment and features of the formation of local quality management systems

Methods. Scientific results are obtained through the use of such methods as description, abstraction and induction. With the help of the method of description, aspects of the evolution of quality management in the educational organization were revealed, in particular, attention was focused on the experience of higher education institutions in Poland, the Czech Republic, and Germany. With the help of the abstraction method, certain aspects of quality management in higher education institutions of Ukraine were singled out and a list of actions was proposed that will contribute to the optimization of certain processes within the framework of ISO 9001:2015. When applying the induction method, the authors made conclusions regarding the possibilities of significant optimization and improvement of the quality management system in higher education institutions of Ukraine. Results. The article investigates and analyzes the features and aspects of the functioning of the quality management system in institutions of higher education, proposes certain elements for implementation in the system of higher education that will contribute to the optimization and improvement of the functioning of processes within the framework of ISO 9001:2015. Novelty. This study revealed and demonstrated that within the framework of the higher education system of Ukraine there are certain characteristics that in one way or another negatively affect the functioning of the educational processes of higher education institutions of Ukraine. Therefore, we have created and proposed methods that can improve and optimize processes in higher education institutions. Practical value. This study can be important and useful for the management of higher education institutions in building an effective quality management system in higher education institutions, which can lead to higher education standards and, as a result, satisfaction of all interested parties.

The Dimensional Effect of Optimal Project Risk Management Practices on Project Quality of Selected Construction Companies in Nigeria

In the construction industry, ensuring high-quality standards is a critical aspect of construction projects and plays a pivotal role in the sustained viability and triumph of contemporary construction companies. However, existing literature highlights the persistently subpar levels of project quality within the construction sector. This situation is manifested through cost overruns, time delays, deficient project definition, and fluctuations in project scope, which are indicative of insufficient project risk management practices. Although several studies have examined project risk management practices, little emphasis has been placed on evaluating their impact on quality in the construction industry. Hence, this study examined the dimensional effect of optimal project risk management practices on project quality of selected construction companies in Nigeria. Survey research design was adopted. The population was 202 top management and mechanical department staff of three selected construction companies in Lagos State, Rivers State, and the Federal Capital Territory of Abuja, Nigeria. A sample size of 176 was found to be usable. A validated questionnaire was adopted for data collection. Cronbach’s alpha reliability coefficients for the constructs ranged from 0.74 to 0.98. The response rate was 87.1%. Data were analyzed using the Smart partial least squares structural equation modeling (PLS-SEM) software, which allowed for the testing of path analysis and hypotheses. A confirmatory factor analysis (CFA) was employed to assess the factor loading of the variables. Findings indicated that project risk management practices had significant effect on project quality of selected construction companies in Nigeria (Adj R2 = 0.54, F2 = 0.058, Q2 = 0.507, p < 0.05). The study concluded that project risk management practices improved the quality of the selected construction companies in Nigeria. The study recommended that project managers should establish and implement effective quality management systems that outline clear processes and procedures for ensuring project quality. Develop quality control plans that include inspection, testing, and monitoring activities throughout the project lifecycle. Incorporate quality management standards and best practices, such as ISO 9001, to enhance quality assurance processes.

Current tendencies in the forming of quality management systems

The article highlights the peculiarities of the formation of modern quality management systems. The need to solve problems related to the development and implementation of highly effective product quality management systems, taking into account the features of European integration, is emphasized. The stages of development of systematic quality management, which, according to the laws of dialectics, evolved under the pressure of contradictions of internal and external goals of product manufacturers are systematized: the stage of rejecting products, quality management, the stage of continuous improvement of product quality, the stage of forecasting and planning the quality of production processes and the products themselves. The advantages and disadvantages of modern trends in the formation of quality management systems are determined. The current state of certification of quality systems of domestic enterprises compared to the dynamics of similar indicators of Polish enterprises is characterized. The importance of developing the documentation necessary for the formation of a quality management system is emphasized; it contains clear and generally understood provisions of tasks in the field of quality; quality guidelines; quality programs; methods of compliance with DSTU ISO 9001 - 2015, etc. Emphasis has been placed on constant purposeful work on the development and harmonization of national standards with European standards, with the aim of adapting and facilitating the activities of domestic producers on the international market. The production of domestic products in accordance with European quality and safety standards will enable Ukrainian manufacturers to expand their export potential for products to the European Union and other countries and be competitive on the world stage. Considerable attention is devoted to aspects of quality system certification. It has been proven that obtaining a certificate is a derivative of the implementation of a quality management system. The modern quality management system in the enterprise is effective when the manufactured products are in demand and the enterprise makes a profit, under such conditions certification becomes a formal procedure. It has been proven that the formation and implementation of quality management systems based on international standards will contribute to new opportunities for the development of domestic business, the elimination of trade barriers, and the establishment of close relationships between the spheres of production, trade, and consumption. Keywords: quality system, standardization, certification, quality management, quality

Quality Management Systems Implementation and their Output on Productivity and Organisational Performance

The companies that struggle with the problem of inefficient resource usage are most likely those with the absence of an effective management system. Organizational performance can be greatly enhanced through the systematic measurement, monitoring, and improvement of the quality of a company's offerings. This paper presents a study that determines the relationship between applying quality management systems (QMS) on organi-zational performance (OP) and impacts and benefits generated by their implementation. The main purpose of the article is to survey the effect of QMS on organisation efficiency based on the concept of change management. Data was collected from randomly selected employees from the top and middle management through questionnaire survey to check the implementation process and effectiveness of QMS. The collected data were analyzed using Statistical Package for Social Sciences (SPSS). The results of this study confirm that there are some positive effects on organisational management variables and establishing training and explanation courses and meetings. Organisational impacts such as efficiency, consumer satisfaction, employee performance, profitability, internal improvement, competitive advantage, supplier relationships and quality of products and services can be also highlighted. The findings from this study are expected to support management’s decision to implement QMS if one of their objectives is to use their resources efficiently. Customer's needs and perceptions are also considered by an adequate feedback system, proper audits, and management reviews. It is shown that QMS can only be successful if top management are persuaded to take a sustained and active role in the implementation process, it is essential to regularly conduct training in this area in order to instill habits and make employees more amenable to the change of working methods.

К вопросу о путях обеспечения качества юридического образования России в 21 веке

The subject of research in this article are the features and patterns of ensuring the quality of education in national research universities, as well as the role of legal regulation in ensuring the formation of an education quality management system in national research universities. The purpose of the study is to consider the patterns of education quality assurance at national research universities, as well as the role of legal regulation in ensuring the formation of an education quality management system at national research universities. Among the research methods that were used in this study include: functional analysis, factor analysis, system analysis. At the same time, system analysis was used to analyze the quality management system at national research universities, functional analysis was used to analyze the functioning of education quality management systems at national research universities. Factor analysis was used to analyze the factors influencing the functioning of the education quality management system in national research universities.
 In the course of the study, it was found that some national research universities, when switching to their own standards in the field of higher education, did not bother about the need to implement an effective quality management system for education, but perceived the right to teach students according to their own standards, as an opportunity to do what we want in the field of higher education, which naturally does not contribute to improving the quality of education and may violate the rights of students. To prevent this kind of thing, it is proposed to develop a concept of legal education in Russia, including effective mechanisms for checking the quality of legal education, which is organized by professional associations in a particular area of professional activity, as well as ways to improve the legal regulation of public relations in the field of quality of legal education.

Does The Indonesian National Standard (SNI) for Products in SMES Influence Cleaner Production Practices? A Snapshot of Best Practices from Yogyakarta, Indonesia

This article investigates the extent to which the Indonesian National Standard (SNI) for products adopted and applied by small and medium enterprises (SMEs) in Yogyakarta, Indonesia, can encourage them to effectively implement a quality management system (QMS) within their internal organizations, which eventually affects and benefits their process performance and clean production practices. Survey data collected from 44 respondents in 12 SMEs with SNI-certified products were processed and examined using descriptive analysis and regression analysis. The results showed that these could implement QMS effectively partly because it is a requirement for the SNI certification of the proposed product. The effectiveness of QMS implementation affects the achievement of process performance in that it can reduce the number of defective products, process costs, and process cycle times. According to the respondents, an effective QMS makes every activity and action taken in the production process more environmentally friendly and leads to cleaner production practices. These findings can help further research determine the model's feasibility to design and develop a better framework that promotes QMS and clean production practices, especially among SMEs in Indonesia.

The effectiveness of the implementation of ISO 9001 on SMEs performance: the case of an emerging economy

PurposeThe study seeks to examine the effectiveness of implementing the ISO 9001 quality management system (QMS) on small and medium enterprises (SMEs) performance in Saudi Arabia. It explores ISO 9001 usefulness through the dimensions of continuous improvement, customer satisfaction focus and prevention of nonconformities. The study investigates two dimensions of firm performance's: operational performance and product/service quality.Design/methodology/approachThe study employs a quantitative method. A simple random sampling technique is used to collect study samples. A self-administered questionnaire is employed as the data collection tool. The study was based on 263 samples from SMEs in Saudi Arabia. Statistical analysis was carried out using SPSS/AMOS.FindingsPrevention of nonconformities, customer satisfaction focus and continues improvement had a positive significant correlation with operational performance and product/service quality. Moreover, the ISO 9001 QMS effectiveness construct showed a helpful and important correlation with the performance of the company.Originality/valueThe study offers empirical evidence to clarify ambiguous findings from past studies, as well as expounds knowledge on the effect of ISO 9001 on SMEs' performance through the lenses of operational performance and quality/service quality.

The effect of quality management system (ISO 9001) on operational performance of various organizations in Indonesia

An organization improves its performance by implementing ISO 9001, but there are not many scientific journals that discuss this. The purpose of this article is to examine the effect of the quality management system (ISO) 9001 on organizational performance to achieve business sustainability. This study examines four variables, namely ISO 9001 certification planning, organizational commitment, application of procedures on organizational performance and quality culture as mediating variable. Data collection was conducted in the form of a survey by e-mailing the questionnaire to 1000 ISO 9001 certified organizations selected using the purpose sampling technique. This research used a closed questionnaire and a Likert scale of 1–5. Data calculation utilized a Partial Least Squares (PLS) analysis to distinguish outer and inner model analyses, as well as to test the hypotheses. The results show that ISO 9001 certification planning, organizational commitment, and application of procedures have a significant effect on quality culture. ISO 9001 certification planning and organizational commitment do not have a significant effect on operational performance, but the application of procedures and quality culture significantly influence operational performance. It is clear that an increase in organizational performance greatly influences by ISO 9001 implementation and a quality culture as a mediating variable.

MINE ACTION CENTER: MAIN ASPECTS OF ACTIVITY AND DEVELOPMENT PROSPECTS

Statement of the Problem. Ukraine is one of the ten countries with the most explosive contaminated territory, and this situation tends to worsen due to the scale of military operations and the use of so-called “mine warfare” tactics. Therefore, the сreation of an effective mine action system, taking into account the needs of safe demining of the territory of Ukraine from explosive objects, is a priority task at the national level.
 Analysis of recent research and publications. The analysis of professional literature has shown that the issues of creating an effective mine action system, improving the regulatory framework based on international experience, problems and ways to solve humanitarian demining, and the impact of explosive hazards on the environment are in the focus of attention of the scientific community. The issue of development and improvement of the mine action system has become even more urgent and requires further development taking into account the principles of international humanitarian law and measures to minimize the danger caused by explosive hazards.
 The purpose of the article is to study the activities and identify promising ways of development of the Center for Mine Action in the conditions of the legal regime of martial law.
 In Ukraine there is an effective mine action system with clear subordination to the National Mine Action Agency. In order to implement mine action measures in practice, the Mine Action Center was established, which has an effective mine clearance quality management system, including certification of mine action operators (Certification Agency) and control of demining quality (Inspection Agency).
 Within the framework of international cooperation, joint projects are implemented with foreign countries, international organizations and institutions, in which the Mine Action Center is an active participant. A system of training and advanced training of the Mine Action Center’s personnel involved in demining has been implemented.
 Promising ways of developing mine action within the competence of the Mine Action Center include the following: expanding the scope of accreditation of the Certification Agency; improvement of normative and legal acts of mine countermeasures (amendments to existing ones and creation of new ones); increasing the effectiveness of mine action tasks by conducting applied and fundamental research within the authority of the scientific research laboratory.

THE IMPACT OF QUALITY MANAGEMENT SYSTEMS ON THE ORGANIZATION PERFORMANCE OF MANUFACTURING FIRMS

Many empirical studies that suggest that ISO certification has no effect on performance continue to cast doubt on the effectiveness of quality management systems (QMS) on performance. This paper examines quality management systems and how they affect the performance of manufacturing firms in Malaysia because of this contradiction and the dearth of empirical studies there. Food processing companies still struggle to put quality management systems into practice in a way that results in improved organizational performance. As a tactic to obtain a competitive edge in the target market through the creation of superior product quality, market growth, and improved customer satisfaction, many manufacturing businesses in Malaysia are still finding it difficult to adopt efficient quality management systems.
 The article offers deeper understandings into the advantages of quality management systems, methods, and concepts that managers should consider for any certification, including ISO, TQM, & others, to be effectively applied and then transfer to improved company performance. The study discovered a significant positive relationship between the competitive performance of a firm and the quality management techniques under investigation. These quality practices—which include top management support, capacity expansion, adoption and exploitation of information technology, and control measures—are essential to achieving and maintaining this competitive performance.
 The study suggests that manufacturing companies should concentrate on changing the organizational culture as a whole in order to make it overtly quality-oriented. In order for the company to reap the rewards of a quality management system, it is essential to regularly conduct training in this area in order to instill habits and make employees more amenable to the change of working methods. Organizations may increase internal efficiency via the use of quality management strategies, which is a must for competing in the global market.

The personnel policy in health care institutions in the light of tasks of provision of medical care quality and medical activity safety

The personnel plays important role in process of maintaining internal quality control and safety of medical care. The employee satisfaction with working conditions is main factor affecting professional development and competence enhancement and consequently quality of medical care. The purpose of the study is to analyze particular personnel policies of the institution and to investigate effectiveness of quality management system regarding health care services. Results. The institution implemented the model of quality management system (ISO 9001-2015) assigning significant role to proper personnel management. The sociological survey was carried out to analyze achieved results and to receive feedback from employees to improve quality management system. The results of sociological survey indicate that the most important targets of personnel policies for 65% of respondents are planning, forecasting skill, competency requirements; for 58% - organization of conditions improving effectiveness of employees; and for 51,7% - maintaining favorable team moral and psychological climate. The employees consider as preferable following ways of professional development: additional training, specialized training programs (78.5%), exchange of experience and communication between Russian and foreign colleagues (51.0%). The analysis established that 61.8% of employees of the institution assume mentoring programs would improve efficiency of new employees. Conclusions. The results of the study revealed that personnel policy of the institution can be improved through implementing particular policies regarding development of employee personal additional competency; of mentoring programs and motivation systems for employees; evaluation of employee individual contribution into achieving the goals of the institution and forming personnel reserve.

Implementasi Manajemen Mutu Terpadu Dalam Meningkatkan Mutu Lulusan Di SMP IT Wahdatul Ummah Kota Metro

This study will examine the obstacles to implementing integrated quality management at SMP IT Wahdatul Ummah Metro City to improve the quality of graduates. This project aims to develop an effective quality management system starting from planning, implementation, and evaluation in order to improve the quality of graduates of SMP IT Wahdatul Ummah Metro City. This qualitative study involves interviewing a representative sample of individuals. This methodology aims to gain a deeper understanding of the experience of the academic community in implementing integrated quality management to address the challenges of education services. Principals, vice principals of curriculum, vice principals for student affairs, teachers, students, and their parents were surveyed for this study. Observation, interviews, and documentation are data collection methods used in this study. Test the validity of the data using triangulation in conjunction with data analysis that utilizes multiple data sources to build a more precise representation. This can be achieved by comparing several sources of information to determine whether they agree. If it is determined that the data is invalid, it is corrected or rewritten. This study found that the implementation of integrated quality management can improve the achievement of school goals, starting from the crucial planning, implementation, and evaluation stages. To improve student achievement and the quality of graduates, it is necessary to define the school's vision, mission, and goals. Programs and activities should be directed to improve student achievement and customer satisfaction. In order for schools to continue to emphasize their goals, all parts of the school service must experience continuous development

FDA Warning Letters: A Retrospective Analysis of Letters Issued to Pharmaceutical Companies from 2010-2020.

PurposeTo launch a pharmaceutical product in the US market, approval from the FDA is required. Pharmaceutical companies undergo FDA pre-approval inspection (PAI for small molecule products) or pre-license approval (PLI for biological products) at their manufacturing sites (including contract development and manufacturing organization, testing laboratories, and packaging labelling facilities) prior to approval. After the products are approved by the FDA, surveillance inspections are performed by the FDA which are risk based as which company and which site will be inspected. The present study examines the causes of warning letters issued by the Center for Drug Evaluation and Research (CDER), FDA to the pharmaceutical companies after post-approval inspections.MethodsWarning letters issued from the time period 2010 to 2020 were obtained from the FDA website, and information about date of issuance, company, and type of violations was extracted for the study.ResultsPoor compliance to CGMP and misbranding were the most common reasons for the warning letters. Detailed analysis of CGMP warning letters elucidated three major types of violations, namely deficiencies in process validation, documentation practices (data integrity), and quality control corresponding to 26%, 21%, and 15% warning letters, respectively.ConclusionReview of the analysed letters demonstrates that the FDA’s major concern is over CGMP compliance. To avoid these warning letters, pharmaceutical manufacturers need to improve their quality compliance and focus on creating effective quality management systems that govern the entire manufacturing process, quality control, employee training, and documentation practice. Companies should develop an internal compliance check list and also be ready for corrective measures as and when required.Supplementary InformationThe online version contains supplementary material available at 10.1007/s12247-022-09678-2.

Challenges of Investigator-initiated Clinical Trials to Support the New Drug Development

在我国开展的大量研究者发起的临床研究（Investigator-initiated clinical trials, IIT），其中部分应该可以为新药研发起到重要的支撑作用。但由于我国IIT尚存在数量多、规模小、质量参差不齐等问题，特别是在方案设计、质量管理以及伦理审查能力等方面与制药企业发起的注册临床试验还存在不小的差距，导致很多IIT还不能用于支持新药研发。因此需要监管部门、申办方、研究机构、伦理委员会和研究者共同提高对于IIT用于支持新药研发作用的认识。只有加强监管，建立有效的质量管理体系、强化对研究者的培训并切实提升伦理审查能力，才能用高质量的研究者发起的临床研究支持新药研发。

The Effect of Quality Management System on Small Business: A Case Study of Somalia

An effective quality management system (QMS) is the foundation of a quality organization, and while many small organizations may not have substantial resources to invest in quality management, it may still be done successfully. Effective QMSs are rigorous procedures that may continuously raise the economic and quality value of products and services. They work to improve the customers' experiences, which is critical for a small business's client retention. The goal of this article is to present a systematic technique for implementing a quality management system in micro and small businesses in Somalia. The purpose of this study is to look at the challenges that lead to the implementation of quality management in small businesses; therefore, to find out how to implement quality management in SMEs

Motivating and Critical Success Factors in the ISO 9001:2015 Implementa-tion of the Provincial Government of Bulacan

Quality is an essential performance measure in both the private and public sector. The adoption of a Quality Management System (QMS)/ISO 9001:2015 standard is a strategic decision that can help improve an organization’s overall performance. This study aimed to assess the ISO 9001:2015 implementation of the Provincial Government of Bulacan in terms of the selected critical success factors and workforce level of motivation and be able to provide recommendations for improvement. This study used the quantitative, non-experimental, descriptive research design, employing survey and correlational approaches. A qualitative approach through qualitative interview was also utilized to capture the implementation strategies. The overall analysis revealed that 8 motivating factors obtained a low level of relationship with all of the selected critical success factors while the 9th motivating factor, Recognition and Feedback Received obtained a high level of relationship with 7 critical success factors indicating that Recognition and Feedback Received can affect the implementation of QMS tasks in terms of the critical success factors. Findings also showed that there is an opportunity in trainings. Leaders can identify training needs to support a more effective QMS implementation. Furthermore, the Provincial Government of Bulacan can revisit and strengthen the performance evaluation process as this can help meet the upper-level self-actualization needs of employees. A quality program with the suggested action plan has also been recommended towards overall performance improvement.