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.

Leveling the Workload for Radiologists in Diagnostic Mammography: Application of Lean Principles and Heijunka

To facilitate the delivery of accurate and timely care to patients in complex environments, process improvement methodologies such as Lean can be very effective. Lean is a quality improvement methodology that seeks to add value for patients and employees by continuously improving processes and eliminating waste. At our institution, Lean principles were applied to improve efficiency and minimize waste in the diagnostic breast imaging reading room. This paper describes how we applied Lean principles, including plan-do-study-act testing, level-loading (heijunka), and visual management, to level the workload of the diagnostic radiologists in our practice. Implementation of these principles to improve the diagnostic workflow in breast imaging is described along with examples from our practice, including challenges and future opportunities.

Releasing Operating Room Nursing Time to Care through the Reduction of Surgical Case Preparation Time: A Lean Six Sigma Pilot Study

Healthcare systems internationally are working under increasing demand to use finite resources with greater efficiency. The drive for efficiency utilises process improvement methodologies such as Lean Six Sigma. This study outlines a pilot Lean Six Sigma intervention designed to release nursing time to care within a peri-operative environment; this was achieved by collaborating with stakeholders to redesign the process for laparoscopic hernia surgical case preparation (set up) material. Across 128 laparoscopic hernia surgical cases, the pilot resulted in a 55% decrease in overall nursing time spent in gathering and preparing materials for laparoscopic hernia surgical cases, with a corresponding reduction in packaging waste. The major impact of releasing nursing time to care within busy Operating Room environments enabled nurses to focus on continuing to deliver high-quality care to their patients and reduce pressure expressed by the Operating Room nurses. The results have led to an ongoing review of other surgical procedures preparation to further release nursing time and will be of interest to perioperative teams internationally.

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 es diseñar una herramienta guía basada en técnicas de mejora continua aplicable a pequeñas y medianas empresas (Pymes) del sector lácteo en América Latina y el Caribe (ALC). A través de una revisión literaria de 753 pymes en 10 países de ALC, se analizan los principales factores que influyen en el desarrollo organizacional y productivo de pymes lácteas. Posteriormente se diseña una entrevista semiestructurada aplicada a 6 pymes lácteas de Veracruz, México y a 6 pymes lácteas de Bogotá, Colombia. Los resultados muestran deficiencias en aspectos como: estructura y desarrollo organizacional, planeación de la producción y relación con proveedores y clientes. Por lo 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 fomentando la evaluación de su desempeño.

Comprehensive Operational Assessment Eliminates Significant Lost Time on a 3-Year Development Project in Nigeria

A 3 year, 23 well project drilled by a major operator in Nigeria was challenged to develop methodologies to optimize every aspect of drilling for a development project to reduce total project time and costs. The team of operator and service company personnel created an approach that systematically examined and challenged the efficiency of all tasks. They then developed and implemented innovative methods to save time by both analyzing repetitive, lengthy, or troublesome operations and challenging many status quo rig activities. The culture of continually challenging the causes of invisible lost time (ILT) that developed resulted in the creation of several critical performance improvement methodologies each of which are explained in detail. The multiple focus areas where process improvements were made included hole cleaning efficiencies, optimizing the ROP to deliver shortest well time from drilling out the casing shoe to landing the next casing, anti-collision practices to drill out conductors with a separation factor of less than 1.0, BHA design efficiencies for equipment standardization and faster make up and break down times, managing differential sticking risks, improving survey times, and developing best practices to side-track with a point-the-bit Rotary steerable system. Exact times were tracked to establish the required baselines and drilling optimization services were introduced to modify the drilling practices to reach the technical limit. The technical limit for ROP was achieved and best practices developed in this environment for effective hole cleaning, ease of tripping, and improved tripping speeds of the BHA at the end of every run saved 38.25 days over 15 wells. Average ROP's were improved by 48% in the 17 ½" section and 57% in the 12 ¼" section. The new anti-collision methodology saved 5 hours per well. BHA assembly and tool download efficiencies saved 11.47 days. Wellbore strengthening techniques prevented seepage losses and reduced stuck pipe events. Surveying improvements saved 11.78 days and new sidetracking practices saved 5 hours per sidetrack. Tasks that could be done in parallel to the critical path were identified and tasks on the critical path were performed more efficiently. ILT elimination in drilling processes saved a total of 96 days of rig time over an established performance baseline during this 23 well project. The operator set two records for the fastest drilled and completed conventional offshore wells in Nigerian history.

FIND-IT: Ultrafast mining of genome diversity

Novel crop improvement methodologies, including the exploitation of natural genetic variation, are urgently required to feed our rapidly growing human population in the context of global climate change. Here we describe a ‘Fast Identification of Nucleotide variants by DigITal PCR’ (FIND-IT) method for the rapid identification of pre-targeted genetic variants or rare alleles in large genomic populations. Libraries of 500,000 individuals can be screened and desired variants isolated within two weeks. FIND-IT is widely applicable for mining valuable diversity in any genomic population, including elite breeding and wild germplasm collections. The method provides single nucleotide resolution that has been validated by identifying and isolating knockout lines, non-synonymous codon changes and variants of miRNA and transcription factor binding sites in the agronomically important crop barley. In contrast to existing methods, FIND-IT does not require transformation, cloning or enzymatic steps, and is exempt from GMO regulations. Thus, FIND-IT can be applied immediately to elite crop cultivars and can be tailored to minimize or eliminate time-consuming backcrossing requirements.

Multicriteria Decision Making to Continuous Software Improvement Based on Quality Management, Assurance, and Metrics

Software process improvement methodologies support to incessantly regulate and advance the process of software for its performance development. This development arises in terms of software product quality, time, changes reduction, and so on. The aim of software process improvement is to make software process effective and to increase quality of software product through continuous evaluation. Various approaches and frameworks are in practice for software process improvement. Early decision making concerning continuous software improvement can ultimately lead to successful software developments and growing software industry and business of software. Keeping in view the early decision making regarding continuous software improvement, the proposed study has considered a decision support system (DSS) for making decision based on multicriteria against quality management, assurance, and metrics. The necessary factors and alternatives for continuous software improvement were considered. The process of the proposed study was experimentally conducted, and results were good enough for supporting the study. The study will help practitioners in early decision making regarding software improvement based on quality management.

Evaluation of the Medication Safety of Chemotherapy Drugs

To evaluate the medication safety of chemotherapy drugs at a tertiary care hospital, with complete reporting of prescription errors, classifying prescription errors, complete detailing of watched medication administration errors (MAEs) by nurses, ordering watched MAEs, and figuring improvement methodologies. Likewise, in relation to side effects, how to overcome side effects, which antiemetic treatments to use, how to survey the appropriateness of requesting and apportioning. An imminent, observational, non-interventional contemplate study was driven at the Oncology Department, Baptist Hospital, Bangalore for half a year. All the data was collected from patient medical records according to case record structure. An aggregate of 70 patients tolerating chemotherapy were observed for information on a sort of side effects, prescription missteps and other relevant information like demographic findings, treatments, and drugs used to manage the adverse effects (AEs) collected from the patient’s medical records. The data was characterized reliant on various parameters. The watched side effects according to different organ frameworks were orchestrated and appeared differently in relation to the distributed writing and bundle embeds. Among the 70 patients, 22 (31.4%) were males and 48 (68.57%) were females. Moreover, the age interval within these two groups was of 20–65. From the 70 patients, the number of chemotherapy cycles was of one for 14 (20%) patients, two for 16 (22.85%), three for 16 (22.85%), four for 5 (7.14%), five for 6 (8.57%), six for 9 (12.85%), and more than six for 4 (5.71%) patients, mostly due to maintenance chemotherapy. The evaluation of our information uncovered that the cancer with the most elevated predominance was breast cancer (24.28%), pursued by blood and bone marrow cancer (5.71%) in females, whereas in males were blood and bone marrow (4.28%), followed by lung cancer (2.85%), non-Hodgkin lymphoma (2.85%), and colon cancer (2.85%). The present study demonstrated that in both gender groups, the most influenced organ framework was gastro intestinal tract (GIT), trailed by skin and subcutaneous tissue, musculoskeletal, blood and nervous system. The most prescribed antiemetic drug was ondansetron (81.42%), and the normally endorsed chemotherapy agents in our setting were shown to be cisplatin (21.42%), carboplatin (17.14%), and paclitaxel (14.28%). The total percentage of errors on the 70 prescriptions was 24.28. Most of the errors were due to drug–drug interactions (10%). The total percentage of errors in drug administration performed by nurses was found to be 11.42%, out of which in 2.85% of the cases, it was used the wrong drug dose. The adverse impacts related with the usage of anticancer medication were surveyed for half a year. The AEs most commonly experienced suggest that for all intents and purposes, all the patients accepting cytotoxic drugs suffered at least one AE. The critical announced MAE rates on our hospital ward (0.04% of medication administration and 0.03% MAE/patient admission) send out an impression of being generally low due to the utilization of current security rules. Emphasize on deep understanding of MAE at individual foundations, is likely going to result in important procedure changes, improved effectiveness of MAE detailing, and various focal points.

Process improvement methodology selection in manufacturing: A literature review perspective

Problems in manufacturing have always been a hurdle for leadership, engineers, and professionals. They can lead to low productivity, poor quality, high costs, and ultimately loss of customers. Problems should be prevented by fair means and following well-established methodologies of continuous process improvement. The present paper addresses this topic, which in both academic and professional literature has been discussed from one single angle–that is, how to use a specific methodology in a certain situation. From that perspective, researchers from academia and consultancy promote the use of a particular method. One of the greatest challenges to researchers and practitioners in manufacturing is to select the right methodology for problem-solving and process improvement. The present paper attempts to address this issue from a literature review perspective. The approach followed is based on the fact that understanding the attributes of process improvement methodologies reported in the open literature and their linkages to the main phases of the continuous improvement process will provide insights on how the selection of the methodologies can be carried out in real manufacturing situations.

Lean and Kaizen: The Past and the Future of the Methodologies

Lean and Kaizen improvement methodologies have been in the entrepreneurship spotlight for a long time. They can be adopted by any kind of enterprise, and they succeed in producing better long-term results, improving their performance, but most important, influencing the philosophy of the organizations implemented. In this research, many case studies and success stories of companies implementing Kaizen or/and Lean methodologies, or even the new Lean Kaizen methodology, will be introduced. We attempt to evaluate the performance of Lean and Kaizen implemented companies and distinguish the elements that made the difference. Maybe, it is some specific tool, or an aspect in the culture that was enhanced, since the implementation of these business process improvement methodologies. Finally, thoughts and estimations will be presented, regarding the future of these methodologies, in the unstable and rapidly changing economic environment.