Continuous Improvement Methodology Research Articles

The Impact of Applying Quality Standards on the Internal Operations in the Public Sector in the Sultanate of Oman

Purpose: The aim of this study is to identify the impact of applying quality standards on the internal operations efficiency in public sector institutions in the Sultanate of Oman along with measuring the effectiveness and efficiency of operations after applying quality standards. Theoretical framework: This study focuses on the definition of quality and its history, quality standards, its types, rational behind their application, continuous improvement methodology which is Deming cycle (plan, Do, check, Act), and defining internal processes and their dimensions. Design/Methodology/Approach: To achieve the objective of this study , the questionnaire was used as a main tool for data collection. Questionnaires were distributed to a simple random sample of 115; 107, questionnaires were retrieved and (102) were suitable for analysis. The data was then analyzed using a variety of statistical techniques (arithmetic means and standard deviations, multiple linear regression analysis using the stepwise method, and Cronbach alpha for stability). Findings: The main findings in this study was identifies that prove there is a gap between quality standereds applications in planning of operations, readiness, and outputs. Research /Practical /Social Implications: This study is significant since it focuses on the influence of applying quality standards in terms of results and effect, specifically on processes and whether there is continuous process improvement. In social indicator it is impacting individuals satisfactions specially when speaking about the customers experience. Moreover, in enconmoical indocators it is indicates improvement of the institutional performance. Originality/ Value: This study is distinguished from previous studies in that it focuses on the impact of applying quality standards in terms of results and effect, specifically on processes. Moreover, this study specially build based on Oman experience.

Design of a guide tool based on continuous improvement methodologies applicable to SMEs in the dairy sector in Latin American y Caribbean countries

El objetivo de la investigación fue diseñar una herramienta guía basada en técnicas de mejora continua aplicable a pymes del sector lácteo en América Latina y el Caribe. A través de una revisión literaria de 753 pymes en 10 países de América Latina y el Caribe, se analizaron los principales factores que influyen en el desarrollo organizacional y productivo de pymes lácteas. Posteriormente, se diseñó una entrevista semiestructurada aplicada a seis pymes lácteas de Veracruz (México) y a seis pymes lácteas de Bogotá (Colombia). Los resultados mostraron deficiencias en aspectos como estructura y desarrollo organizacional, planeación de la producción y relación con proveedores y clientes. Por tanto, el diseño de la herramienta guía integra técnicas de mejora continua e indicadores que permitan a las pymes lácteas administrar y controlar sus procesos de manera clara, sencilla, y fomentar la evaluación de su desempeño.

405 Integrating a Learning Health System Framework Into a Large Academic Medical Center

OBJECTIVES/GOALS: The Learning Health System (LHS) framework at Columbia University Irving Medical Center (CUIMC) aims to optimize health system performance through enhancing the patient and care team experience, reducing inequities, costs and improving population health outcomes, through a collaborative, interdisciplinary and data driven approach. METHODS/STUDY POPULATION: In alignment with the Quintuple Aim, the LHS program at CUIMC is composed of five critical components: data integration (particularly using Epic EHR and real-time informatics data), utilization of evidence-based practices, a methodology for continuous improvement, and leadership commitment. Our methodology incorporates an iterative process improvement project cycle into an integrated infrastructure and governance of an academic medical center and its hospital partners to fulfill rapid project design and implementation. The LHS at CUIMC aims to bring a cultural shift through stakeholder engagement, symposia, training, accelerated pilot award opportunities, and building external partnership engagement. RESULTS/ANTICIPATED RESULTS: At CUIMC, our definition of a successful integration of a LHS framework is a cultural shift in thinking, method, and continuous improvement. The LHS program has developed multidisciplinary teams that are involved in defining and sharing data, design, and project management resources. In 2021, the first annual symposium was launched and brought together over 200 stakeholders from across the organization to support continuous education, training, and scaling of the framework. As a result of this foundation, two pilot initiatives have been funded and launched, the innovation accelerator model developed and is supporting over ten unique innovative and transformative clinical and operational programs, and several research grant applications have been submitted citing learning health system methodologies. DISCUSSION/SIGNIFICANCE: Our LHS framework has broken down silos and institutional barriers, creating a network of stakeholder groups. Our interdisciplinary approach has enabled us to create sustainable processes, resources and training on rapid, rigorous design, evaluation and implementation of interventions using real-time informatics data and digital health tools.

Gestión del conocimiento para el proceso de innovación en las organizaciones

Every hundred years throughout history there has been a strong transformation, in a matter of years society is reorganized, its worldview, its basic values, its social and political structures, its production structures, there is a new world, our era is a period of transformation and innovation. At this present time the transformation is not limited to Western or Eastern society or history. There is only world history and civilization. In this context, knowledge is the main resource for individuals and for the economy that make up an organization or company, whose main purpose is the integration of specialized knowledge in a common good, which facilitates innovation processes as a strategic factor allowing excellence, valuation and international recognition of an organization. That is why innovation processes in organizations become relevant for having their own and different characteristics such as information, data and knowledge, as well as their transformation, technological surveillance and technology itself, foresight, competitive intelligence and the same impulse of creativity in the conception of ideas and intellectual property that at any time of the innovation management process will be influenced by these aspects, contributing to new business models in organizations. Although innovation processes are changeable and unpredictable, they can be systematized and organized through an innovation management system based on the application of the continuous improvement methodology. Innovation processes interrelated with the vertiginous advances of knowledge have modified the narrow framework of microeconomics, with innovative business models connected to a Knowledge Based Economy, through networks supported by powerful technologies that influence the dynamic capabilities that allow organizations to connect and identify the types of customers or users to configure the supply chain that adds value and allows monetization in a common good. For this reason it is increasingly significant the existence of organizations that recognize the importance of knowledge management and innovation management as a key factor that allows the agile and modern creation of successful business models that generate value, are profitable, transcend over time and leave a deep mark in a globalized market, even in environments characterized by uncertainty, volatility, ambiguity and complexity.

A Data Quality Framework for the European Health Data Space for secondary use

Abstract A cornerstone in the development of the European Health Data Space for secondary use of data (EHDS2) is the design, implementation and assessment of a Data Quality Framework (DQF). Consistently, the Joint Action TEHDAS has a dedicated work program where, learning from others’ experiences across Europe and abroad, the work package is building the concepts and methods for such a DQF. The scope of this work program is to provide recommendation to the Member States and the European Commission on the concept of DQF to foster, where (institutions) the DQF should be implemented, when in data life cycle, how should be implemented and by whom. In terms of the concept, the DQF raises the importance of quality assurance procedures at data processor level and the level of quality of the data collections in terms of reliability, relevance, timeliness, coherence, coverage and completeness. When it comes to when along the data life cycle, DQF is expected operate when data needs harmonization at data processor level (ie, the effective application of interoperability standards), in the publication of the data sources (ie providing users knowledge on the provenance of data and the content of data source); or, when data sources have to be integrated and sensitive data pseudonymized (ie, the quality of the linkage and losses after pseudonymisation). Finally, when it comes to the methodology, TEHDAS suggests a three-fold approach - some quality measures in the DQF could be translated into legislation (eg, the requirement of regular auditing for a data processor to be a trusted party in the EDHS2); some could be kept as good-practices (eg, recommendation of archival procedures when a research project finalizes); and, under the assumption of continuous data quality improvement, an assessment, benchmarking and promotion methodology (eg, a grading system at data processor level).

INTEGRATED QUALITY MANAGEMENT TO CREATE A SCHOOL AS A CENTER OF EXCELLENCE AT JUNIOR HIGH SCHOOL IN BANDUNG CITY (Description Study at SMP Negeri 5 and SMP Negeri 3 Bandung)

Schools are providers of formal education and centers of excellence for human empowerment. Salis stated that Integrated Quality Management (MMT) is “a philosophy of continuous improvement methodology, which provides a set of practical tools for every educational institution in meeting the needs, wants, and expectations of customers, current and future”. In general, the purpose of this study is to describe and analyze the concept of developing quality schools as MMT-based centers of excellence with the development of excellent services. This study uses a qualitative approach and data sources through interviews, observations and documentation through the principal, vice principal, teachers, and students. The results of data analysis showed that the principal's leadership in implementing MMT in SMP Negeri 5 and SMP Negeri 3 Bandung was quite effective in accordance with school planning. This is marked by the principal's continuous efforts to make improvements and changes as a whole in achieving quality, so that schools are realized as a source of excellence. The general conclusion is that the principal has management capabilities that are implemented in schools as a place for comfortable, harmonious, fun and quality education, as well as being highly competitive and having effective management supported by superior human resources to produce superior human resources with target achievement. set.

G Is for Geometric: A G-Chart Primer for Surgeons

In this issue of The Annals of Thoracic Surgery, Glenn and colleagues1 detail their experience with development, implementation, monitoring, and evaluation of a surgical wound infection (SWI) prevention bundle in a high-volume congenital heart surgery program. The study is a valuable and elegant example of applied modern continuous quality improvement (CQI) methodology, and I applaud the authors for their contribution. The authors’ use and evaluation of g-charts should be highlighted. A g-chart is a type of statistical process control (SPC) chart.

A Review of Lean Methodology Application and Its Integration in Medical Device New Product Introduction Processes

The purpose of this study is to review the Lean tool application and its utilisation in medical device design and the new product introduction process to establish the benefits and best practices for its integration with existing new product introduction processes. A review of the literature on the current state of medical device New Product Introduction (NPI) processes is completed along with a comprehensive review of the literature on the history and development of Lean NPI. The review indicates that Lean can be combined with the predominant NPI execution tools, Stage-Gate and Concurrent Engineering within the medical device industry to achieve a best-in-class continuous improvement methodology within the NPI process. This integration eliminates waste, focusses on customer value, and ultimately reduces cost and lead time to market. This review highlights for the first time the main challenges and issues with Lean in the medical device sector NPI processes, identifying possible future strands of research. Limitations of the current review are that despite the heavy emphasis placed on Lean manufacturing processes, comparatively little emphasis is placed on the use of Lean in the medical device NPI process. Future longitudinal case studies on case study application of Lean in medical device NPI processes would be useful. This study has implications for identifying best practices for Lean in NPI in the device industry, improving what is considered state-of-the-art for the introduction of devices into the public domain.

The Impact of The Kaizen Methodology for Continuous Improvement on Job Performance An Applied Study on The Employees of Imperial Knight Holding Company, Sulaymaniyah Governorate

The research dealt with the concept of the Kaizen methodology for continuous improvement and job performance, This research aimed to identify the extent of the impact of the Kaizen methodology for continuous improvement on job performance, by addressing the main problematic about knowing the impact of the Kaizen methodology for continuous improvement on job performance, the descriptive approach was adopted in the aspect Theoretical As for the practical side, a questionnaire was relied on to collect the initial data which has been distributed it to the research sample, which was represented by all employees of the Imperial Knight Company, the number of valid and approved forms reached (41), and in sight of this, data were collected and analyzed, and the research hypothesis was tested. The statistical program (SPSS) version (24) has been used for purpose of analysis of data, and the research reached a number of results, the most important of which was that there is a statistically significant effect of the Kaizen methodology for continuous improvement on job performance. and one of the most important recommendations made by the research is the need to provide a good communication system to contribute to the continued participation of workers in the continuous improvement processes effectively.

Continuous production improvement concept for shipbuilding enterprises

Aim. The presented study aims to investigate a relevant quality management method and to propose ways of adapting the continuous production improvement methodology to the operating conditions of a shipbuilding enterprise.Tasks. The authors describe a productive management system and effective lean production tools; popularize commitment to continuous improvement at every workplace and in every production process of a shipbuilding enterprise; describe an algorithm for the continuous improvement of production processes to increase labor productivity.Methods. This study uses systems analysis, synthesis, and methods of logical analysis to systematize existing approaches, basic tools, and methods of quality management, in particular the concept of continuous improvement for enterprises.Results. Adapting the concept of continuous improvement for shipbuilding enterprises and becoming a lean enterprise requires not only a special management style, but also a new way of working through new thinking and attitude to work. For this, corporate culture should focus providing value for the consumer and continuous improvement.Conclusions. The concept of continuous improvement and lean production based on a constant desire to eliminate all types of losses and a technology for steadily reducing costs; active involvement of employees in the transformation of the enterprise in the context of limited resources and strong competition — all this will increase the competitiveness and stability of the shipbuilding enterprise in the market.

An empirical study into the reasons for failure of sustaining operational excellence initiatives in organizations

PurposeOperational excellence (OPEX) initiatives such as Lean, Six Sigma, Lean Six Sigma and Agile have some common characteristics that can be understood through their adoption in organizations. The objective of this research is to present the results of an online survey highlighting the most critical reasons for failure of OPEX initiatives.Design/methodology/approachThis study presents the results of a survey from 106 experts from different countries who have been involved in OPEX implementation. The experts were Six Sigma Master Black Belts, Black Belts and Champions from different manufacturing and service organizations. The developed questionnaire was initially tested with the help of seven experts to ensure their technical validity and soundness.FindingsThe study found 15% of companies surveyed have not adopted any form of OPEX methodology. The top three reasons for non-adoption of OPEX were also found. In terms of the use of various OPEX methodologies, more than 75% of companies were employing Six Sigma and less than 50% were engaged in Lean initiatives. Another surprising result was that less than 5% of the companies were utilizing Kaizen and other continuous improvement methodologies for improving the efficiency and effectiveness of organizational processes. The study further finds top five failure factors for sustaining OPEX initiatives in manufacturing, service, large and small organizations.Research limitations/implicationsThe study reports the outcomes based on an online survey with limited sample size. Moreover, the number of samples from small and medium-sized enterprises (SMEs) was less than 25, and therefore it was difficult to make any robust conclusions in the comparison of failure factors between large enterprises and SMEs.Originality/valueTo the best of the authors’ knowledge, this is the first empirical study that has attempted to explore the reasons for failure of OPEX initiatives. The authors argue that a greater understanding of the reasons for failure of OPEX initiatives can provide an input to develop a framework that can mitigate the failures and costs associated with such failures.

Improving Timeliness of Pediatric Emergency Department Admissions

IntroductionThe goal of this quality improvement project was to improve timing, communication, and continued care for pediatric patients who present to the emergency department at a Level I pediatric trauma center and require inpatient admission. MethodsUsing continuous improvement methodology, a patient flow process was created to improve the throughput of pediatric patients requiring inpatient admission from the emergency department, aimed at decreasing the time from decision to admit to actual admission. The new workflow included ED and inpatient nursing collaboration, with nursing leaders coordinating patient transfer. ResultsBaseline data indicated that, in 2019, patients admitted to a short-stay pediatric unit from the emergency department had an average time of 106.8 minutes from decision to admit to the actual admission. After the implementation of a new admission process, time from decision to admit to actual admission decreased from a mean of 106.8 minutes to 82.84 minutes for patients admitted to a short-stay unit. This illustrates an improvement from 59.75% to 68.75% of patients admitted within 60 minutes from ED admission to arrival on a short-stay unit. This model was then replicated throughout other units in the hospital. DiscussionThere are no known benchmark data to guide practice for rapid admission from the pediatric emergency department to inpatient units and continuing care. This quality improvement project demonstrates a model that has been successful admitting patients in an efficient, time-controlled manner. Additional research is needed to document benchmarks for admission timing and to demonstrate other measurable outcomes in patient care.

A lean-sprint approach to protocol development.

e18639 Background: With the ever-increasing complexity of protocols and their required approvals, there is a need to improve the time and reduce the effort required to create a Phase III protocol. The objective of this research was to reduce from months to weeks the time to create a Phase III protocol at a large global pharmaceutical organization, while maintaining or improving the quality and scientific merit of the protocol. Methods: The method required two phases: process redesign and process execution/performance. For the first phase, a continuous improvement methodology (Lean), was utilized. In a multi-team-based approach, the first stage (process-prep) focused on the development of the initial draft protocol. The second stage used the concept of a Sprint, a process to complete all protocol changes and approvals within a rapid time span, while simultaneously guaranteeing protocol quality. A set of policies, procedures, and information technology tools were developed to facilitate both efforts. The Process-prep stage was team-based, where a streamlined Clinical Study Team and a sub-group, the Protocol Working Group, identified all the key tasks, activities and their associated completion dates, and created an 80% complete draft protocol. The Sprint was a one-week, intensive effort by all those responsible for creation of the protocol, and for its final approval. Working virtually and internationally allowed for a continuous 24-hour effort during the Sprint. One key element of success was the use of a visualization tool for the creation, adaptation, and finalization of the protocol’s schedule of assessments (SOA) which both assured that all assessments were required by the protocol and that there was concordance between the protocol and the SOA. Results: Quantitative results were significant: a completed protocol was created with a 50% reduction of time compared to the last protocol written by the molecule group, reduction of avoidable amendments, reducing missed errors and potentially decreasing the number of protocol amendments and the near elimination of process loops and email-chains. Qualitatively, team members were trained on useful process tools and methods, while also increasing their comfort level in active participation in remote meetings. This resulted in faster time to create any amendments that may be required in the future for the protocol. Conclusions: It is possible to employ efficiency and effectiveness methods, such as Lean and Sprint, that have been used successfully in other industries in the pharmaceutical research & development process. While using such concepts requires a great deal of initial planning, the rewards of using them are significant. Likewise, the extensive use of interdisciplinary remote teams will be of increasing importance in a post-COVID environment of clinical research.

OVERHEAD ALLOCATION TECHNIQUES AND FINANCIAL PERFORMANCE

In recent years sales of cellular connection has become the fastest growing industry and one of the major areas of domestic and global telecommunications markets. The rapid growth of information flows requires accelerated development of the cellular market and continuous improvement methodology, economic theory, and methods of analysis and management in this area. The most important tasks of modern management practices are to develop and implement decisions to achieve financial and economic stability and efficiency of the organization.In this regard, there are problems with the need to develop, apply, and perspective development of theoretical-methodological and administrative - actual methods to cost analysis and product costs in the economic activities of mobile companies, which determines the relevance of the research topic. All this leads to problems associated with the need to develop theoretical and methodological, organizational, and practical approaches of management analysis of cellular companies in the modern economy of our country and determines the relevance of the research topic. From a cost management standpoint, the research suggests that manufacturing organizations employ the ABC method since it allocates overhead expenses more correctly than alternative cost accounting systems. Adopting this approach will result in: a) a better knowledge of the business processes that drive costs, b) a better technique for identifying productivity improvements that improve service delivery, and c) a clear identification of the performance metrics that improve cost management. These are critical elements of continuous improvement and comprehensive quality management programs that are critical to achieving an organization's objectives, goals, and, ultimately, financial success. Keywords: over head, costs, economic development

Integrating Theory of Constraints, Lean and Six Sigma: a framework development and its application

This paper presents an integrated framework that combines the strengths of three relevant business excellence philosophies: Theory of Constraints, Lean, and Six Sigma (TLS). The integrated framework increases the TLS Orientation of a firm when management employs a unique growth-oriented mindset, adopts global measurements, and implements an integrated continuous improvement methodology. We discuss how a small-to-medium enterprise (a real but disguised manufacturing firm in India) implemented the proposed framework by employing the cognate key concepts and tools in an integrated manner, and improved its business excellence in terms of improved flow, reduced waste, and increased process capability, which, in turn, strengthened its financial performance. We conclude the paper by discussing the limitations of the study (e.g. an application in a small business) and providing future research directions to further develop its underlying theory and validate the proposed TLS orientation construct by means of case studies and questionnaires. Some initial results are reported.

Critical failure factors for continuous improvement methodologies in the Irish MedTech industry

PurposeThe main objective of this study is to investigate what are the critical success factors that exist for continuous improvement (CI) methodology deployment in the Irish medical technology (MedTech) industry. The research will, in particular, seek to establish if the highly regulated nature of the global MedTech industry is an additional critical failure factor (CFF) for the deployment of CI methodology. The study involves the analysis of the benefits, challenges, CFFs and tools most utilised for the application to the deployment of CI methodologies in the Irish medical device (MD) industry.Design/methodology/approachA quantitative survey was utilised in this study. The main participants were made up of senior quality professionals working in operational excellence, quality consultants, quality directors, quality engineers, quality managers and quality supervisors working in both manufacturing and service sectors from Irish MD companies. A total of 94 participants from the Irish MedTech industry responded to the survey.FindingsThe main finding of this study is that 42% of participants perceived that a highly regulated environment was a CFF to CI, whilst 79% of respondents utilised Lean Six Sigma in their organisations, and productivity and financial factors were found to be the highest reasons for CI deployment amongst the Irish MedTech industry. The top CFFs highlighted for CI in regulated industries were fear of extra validation activity, compliance versus quality culture and a regulatory culture of being “safe”. Another relevant finding presented in this paper is that just over 48% of participants felt that CI tools are very strongly integrated into the industries quality management systems (QMSs) such as the corrective and preventative action system, non-conformance and audit systems.Research limitations/implicationsAll data collected in the survey came from professionals working for Irish indigenous and multinational MedTech companies. It is important to highlight that n = 94 is a low sample size, which is enough for a preliminary survey but reinforcing the limitation in terms of generalisation of the results. A further study on a wider European and global scale as well as a comparison with the highly regulated pharma industry would be informative.Originality/valueThe authors understand that this is the very first research focussed on the CFFs for CI in the MedTech/MD manufacturing industry with a specific focus on the highly regulated nature of the industry as a potential CFF. The results of this study represent an important first step towards a full understanding of the applicability and use of CI in the medical-device-manufacturing industries on a global scale.

S128: CONTINUOUS QUALITY IMPROVEMENT IN PAEDIATRIC SICKLE CELL DISEASE

Background: Sickle cell disease (SCD) is characterised by severe episodic pain requiring prompt and effective analgesia. However, SCD patients frequently experience poor quality of care due to lack of awareness of the condition among non- specialist staff, pre-conceived biases and unfounded allegation of drug-seeking behaviour. Several reports and surveys using Patient Reported Experience Measure (PREM) tools indicate widespread prevalence of ineffective pain relief in emergency department(ED), poor access to psychological therapies and poor funding for service development. Aims: To use a validated PREM tool to survey patients or carers of sickle cell disease within the paediatric service of a Specialist Haemoglobinopathy Team. To use an established Continuous Quality Improvement (CQI) methodology (5-D’s-define, describe, design, deliver, digest) to ensure sustained improvement in patient- reported areas of service deficit. Methods: The PREM survey was conducted as part of a network- wide initiative in 2018. The survey responses were analysed and problem scores created for specialist care, emergency care, ward-based care, information and support. These problem areas were categorised into domains where further improvement action was needed. CQI tools were used to map the patient journey within Emergency Department (ED) when presenting with pain followed by thematic analysis to identify potential improvements in the patient journey. Results: The PREM survey analysis identified three domains for improvement: Domain A: To improve the effectiveness of pain relief and quality of empathic and informed care to paediatric sickle cell patients and their families in ED. We developed multi-disciplinary teaching videos with patient involvement and patient information material based on ED/pain/sickle staff feedback. Excellent engagement from all staff groups obtained. Patient involvement in ED teaching video was well received. Thematic analysis of ED process mapping highlighted need for sustained staff education and re-writing ED pain protocol to align with current practice. Pre-conceived biases were identified among staff with respect to attributing drug-seeking behaviour to patients during severe sickle cell pain. Domain B: To improve the information presented to children regarding SCD and the care services available in our trust We developed child friendly Information leaflets targeting primary school age and secondary school age readers Domain C: To improve the availability of, and access to, mental health services for paediatric SCD patients. We developed virtual parent support groups and psychological health screening for adolescent patients in clinics. We organised a ‘Tree of Life’ (ToL) patient empowerment workshop. The parent support groups were well attended. Plans are in place to continue ToL workshops and support groups on a regular basis. Future work: A rapid improvement workshop is being planned to engage a wider multi-disciplinary team to engender a culture of empathy in line with our trust values. Further input from workshop is expected to identify and implement sustainable goals. We plan to undertake a repeat PREM survey following the end of this CQI project to understand the impact and the implemented improvements.

Sustainable continuous improvement programs

Continuous improvement programs in their various forms have proven their capabilities in creating value for a company, but often fail to have a lasting impact. The reason is its management and engineers gradually lose incentive and fall back into longstanding ways because they fail to consistently meet their objectives, solving ill-posed inverse problems. The unsustainable executions and results are costly and take more unnecessary time for the company to attain high return on investment. This article examines three key tenets of the continuous improvement programs, i.e., deployment, methodology, and common tool. Behavioural economics approach, scientific principles, and causal inferences based on Bayesian statistics are applied to guide us in evaluating the key tenets. The guidance is used to extract the prerequisites of the mindset development of understanding and improving the mechanism of the true causality and reasoning process to uphold continuous improvement intended goals, i.e., perpetually better quality, and capability improvement.

Barriers and Enablers for Continuous Improvement Methodologies within the Irish Pharmaceutical Industry

This study aims to investigate the barriers that exist when implementing continuous improvement methodologies, such as Lean Six Sigma (LSS), within the Irish Pharma industry. The main finding of this study is that 45% of participants perceived that a highly regulated environment could be a barrier to continuous improvement implementation, while 97% of respondents utilised Continuous improvement (CI) methods, such as Lean, Six Sigma, and LSS, within their organisations. While the International Conference of Harmonisation integrates CI into its Pharmaceutical Quality Systems (PQS) regulations, the highest motivation for CI implementation amongst the Irish Pharma industry is to improve Productivity and Quality. The main obstacles highlighted for CI implementation in Pharma attributed to stringent regulatory regimes were fear of extra validation activity, a compliance versus quality culture, and a regulatory culture of being “safe”. Another relevant finding presented in this paper is that participants CI LSS tools are very strongly integrated into the pharma industries corrective and preventative action system, deviations, and internal audit systems. Limitations of the research are that all the data collected in the survey came from professionals working for multinational Pharmaceutical companies based in Ireland. The authors understand that this is the first research focused on the barriers and status of CI initiatives in the pharmaceutical industry. The results of this study represent an important step towards understanding the enablers and obstacles for the use of continuous improvement methodologies in pharmaceutical manufacturing industries on a global scale.

Creativity and Innovation to Improve Processes in a Textile Industry

In this scientific work, the My Creative Idea (MIC) program was created and developed in the Coteminas S.A. textile industry, distributed among the organization's units in the country with emphasis on the São Gonçalo do Amarante unit in the state of Rio Grande do Norte. The aim was to critically analyze the improvements of industrial-scale processes resulting from the creativity and innovation intrinsically incorporated and experienced daily in the program. Thus, the general objective of the work was to evaluate the improvements in the productive processes coming from an innovation program in a textile industry, considering as specific propositions with respect to calculating the gains with reduction of losses, cost of implementation of ideas and measure financial returns and evaluate employee satisfaction according to the program. Moreover, there was free access in the company to be able to collect valuable information that could formalize a robust database for later structuring of the document, as well as the application of action research in the form of questionnaires. Therefore, the results verified clarified and emphasized the program's aggregating character to the organization in a general way under aspects that approach the financial spheres, the quality, and the satisfaction and motivation of the employees involved in this whole scenario. I suggest continuing to work on a continuous improvement methodology to further enhance My Creative Idea over the years, as well as insert this method of work to units that have not incorporated this program into their business strategies.