A Lean Six Sigma framework to enhance the competitiveness in selected automotive component manufacturing organisations

Background: Currently, globalisation, economic uncertainty and fluctuating market demands prompt leaders all over the world to improve their operations and to enhance innovations in processes, products and services in a very reactive manner. Literature shows that the adoption of an integrated Lean Six Sigma tool can assist them to compete with the rest of the world in a manner where productivity, quality and operational costs reduction are crucial for economic success.   Aim: This article investigates the integration of Lean and Six Sigma tools as a unified approach to continuous improvement and develops a Lean Six Sigma framework for selected automotive component manufacturing organisations in KwaZulu-Natal (KZN), South Africa.   Method: The quantitative methods of research were adopted. The target population (42) was organisations within the Durban Automotive Cluster of which five were used for the pilot work. An empirical study was conducted using a survey questionnaire in measurable format to gather practical information from the sample organisations on the status of their existing business improvement programmes and quality practices.   Results: The results of the study demonstratedthat the organisations had a very low success rate of Lean and Six Sigma adoption as standalone systems, as they found it difficult to maintain the transition from theory to practice.   Conclusion: Hence the adoption of an integrated Lean Six Sigma approach was absent and it can be concluded that the proposed Lean Six Sigma framework affords the KZN automotive sector a unique opportunity to integrate and operate with both tools of quality that complement its management style and industry demands

The Convergence of Quality and Digitalisation in a Changing World: Implications for Developing Nations such as the BRICS Group

The emergence of digitalisation and the Fourth Industrial Revolution has resulted in a significant shift in practices, resulting in a disconnection among organisations, employees, and technology, particularly affecting developing nations like the BRICS group which have faced disproportionate challenges due to the COVID-19 pandemic. The aim of this paper is to explore the role of quality in the context of intelligent and automated systems operating in a technologically advanced environment. The study employs a systematic literature review methodology, which encompassed a rigorous process of identifying and selecting 38 articles, followed by a comprehensive thematic analysis. The findings highlight that organisations need to adapt their quality systems to effectively operate in a world dominated by intelligent and automated systems. The implication is that by leveraging digital technologies, organisations can embrace the integration of quality with machine learning, programmable logic controllers, adaptive feedback loops, automated information collection, and blockchain technology to develop a value-based, transparent, and secure quality system. The proposed roadmap and model derived from this study affords organisations the opportunity to establish an intelligent quality ecosystem that aptly aligns with the requisites of the technologically advanced era, thereby ensuring the attainment of excellence in quality during the digital era

HIV-1 drug resistance in adults and adolescents on protease inhibitor-based antiretroviral therapy in KwaZulu-Natal Province, South Africa

Objectives: In low–middle-income countries, increasing levels of HIV drug resistance (HIVDR) on second-line protease inhibitor (PI)-based regimens are a cause for concern given the limited drug options for third-line antiretroviral therapy (ART). We conducted a retrospective analysis of routine HIV-1 genotyping laboratory data from KwaZulu-Natal, South Africa, to describe the frequency and patterns of HIVDR mutations and their consequent impact on standardised third-line regimens. Methods: This was a cross-sectional analysis of all HIV-1 genotypic resistance tests conducted by the National Health Laboratory Service in KwaZulu-Natal (January 2015 to December 2016) for adults and adolescents (age ≥10 years) on second-line PI-based ART with virological failure. We assigned a third-line regimen to each record based on a national treatment algorithm and calculated the genotypic susceptibility score (GSS) for that regimen. Results: Of 348 samples analysed, 287 (82.5%) had at least one drug resistance mutation (DRM) and 114 (32.8%) had at least one major PI DRM. Major PI resistance was associated with longer duration on second-line ART (aOR per 6-months = 1.11, 95% CI 1.04–1.19) and older age (aOR = 1.03, 95% CI 1.01–1.05). Of 112 patients requiring third-line ART, 12 (10.7%) had a GSS of <2 for the algorithm-assigned third-line regimen. Conclusion: One-third of people failing second-line ART had significant PI DRMs. A subgroup of these individuals had extensive HIVDR, where the predicted activity of third-line ART was suboptimal, highlighting the need for continuous evaluation of outcomes on third-line regimens and close monitoring for emergent HIV-1 integrase inhibitor resistance

HIV-1 drug resistance by ultra-deep sequencing following short course zidovudine, single-dose nevirapine, and single-dose tenofovir with emtricitabine for prevention of mother-to-child transmission

Antiretroviral drug resistance following pMTCT strategies remains a significant problem. With rapid advancements in next generation sequencing technologies, there is more focus on HIV drug-resistant variants of low frequency, or the so-called minority variants. In South Africa, AZT monotherapy for pMTCT, similar to World Health Organization option A, has been used since 2008. In 2010, a single dose of co-formulated TDF/FTC was included in the strategy for prevention of resistance conferred by single-dose nevirapine (sd NVP). The study was conducted in KwaZulu-Natal, South Africa, among pMTCT participants who received AZT monotherapy from 14 weeks of gestation, intrapartum AZT and sd NVP, and postpartum sd TDF/FTC. Twenty-six specimens collected at 6 weeks post-delivery were successfully sequenced using 454 ultra-deep sequencing. Non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance was detected in 17 of 26 (65%) patients, 2 (7%) had Thymidine analogue mutations, and 3 (11%) had K65R. Of the 17 patients with NNRTI resistance, 11 (65%) had high-level NNRTI resistance, whereas 6 (35%) had intermediate NNRTI resistance. The levels of NNRTI resistance are much higher than would be expected, given the inclusion of antepartum AZT and postpartum TDF/FTC. This high level of NNRTI resistance could impact future NNRTI-containing treatment for a large proportion of pMTCT-exposed women. The detection of Thymidine analogue mutations highlights the need to understand the clinical impact of these on AZT-containing antiretroviral treatment in women exposed to AZT monotherapy

Omecamtiv mecarbil in chronic heart failure with reduced ejection fraction, GALACTIC‐HF: baseline characteristics and comparison with contemporary clinical trials

Aims: The safety and efficacy of the novel selective cardiac myosin activator, omecamtiv mecarbil, in patients with heart failure with reduced ejection fraction (HFrEF) is tested in the Global Approach to Lowering Adverse Cardiac outcomes Through Improving Contractility in Heart Failure (GALACTIC‐HF) trial. Here we describe the baseline characteristics of participants in GALACTIC‐HF and how these compare with other contemporary trials. Methods and Results: Adults with established HFrEF, New York Heart Association functional class (NYHA) ≥ II, EF ≤35%, elevated natriuretic peptides and either current hospitalization for HF or history of hospitalization/ emergency department visit for HF within a year were randomized to either placebo or omecamtiv mecarbil (pharmacokinetic‐guided dosing: 25, 37.5 or 50 mg bid). 8256 patients [male (79%), non‐white (22%), mean age 65 years] were enrolled with a mean EF 27%, ischemic etiology in 54%, NYHA II 53% and III/IV 47%, and median NT‐proBNP 1971 pg/mL. HF therapies at baseline were among the most effectively employed in contemporary HF trials. GALACTIC‐HF randomized patients representative of recent HF registries and trials with substantial numbers of patients also having characteristics understudied in previous trials including more from North America (n = 1386), enrolled as inpatients (n = 2084), systolic blood pressure &lt; 100 mmHg (n = 1127), estimated glomerular filtration rate &lt; 30 mL/min/1.73 m2 (n = 528), and treated with sacubitril‐valsartan at baseline (n = 1594). Conclusions: GALACTIC‐HF enrolled a well‐treated, high‐risk population from both inpatient and outpatient settings, which will provide a definitive evaluation of the efficacy and safety of this novel therapy, as well as informing its potential future implementation

A randomized trial of anesthetic induction agents in patients with coronary artery disease and left ventricular dysfunction

The deleterious effects of anesthetic agents in patients suffering from coronary artery disease are well known. The risk increases when a patient has compromised ventricular function. There is a paucity of literature regarding the choice of the suitable agent to avoid deleterious effects in such patients. The use of etomidate and propofol has been considered superior to other intravenous anesthetic agents in these groups of patients. The aim of the present study is to compare the hemodynamic effects of anesthesia induction with etomidate, thiopentone, propofol, and midazolam in patients with coronary artery disease and left ventricular dysfunction. This randomized clinical trail was conducted at the All Indian Institute of Medical Sciences, New Delhi, India. Sixty patients with coronary artery disease and left ventricular dysfunction (ejection fraction &lt; 45&#x0025;) scheduled for elective coronary artery bypass surgery participated in this study. After stabilization baseline hemodynamic data stroke volume variation and systemic vascular resistance index were recorded for all patients (Flo Trac TM sensor with Vigileo cardiac output monitor used for hemodynamic monitoring). The patients were randomly alloted to one of the four groups and the intravenous induction agent was administered for over 60 - 90 seconds (Group E - Etomidate 0.2 mg/Kg; Group M - Midazolam 0.15 mg/Kg; Group T - Thiopentone 5 mg/Kg; Group P - Propofol 1.5 mg/Kg). Hemodynamic data were recorded at one minute intervals starting from induction till seven minutes after intubation, - the end point of the present study. There was a significant decrease in the heart rate in comparison to the baseline(-7 to -15&#x0025;, <i>P</i> = 0.001), mean arterial pressure (-27 to -32&#x0025;, <i>P</i> = 0.001), cardiac index (-36 to -38&#x0025;, <i>P</i> = 0.001), and stroke volume index (-27 to -34&#x0025;, <i>P</i> = 0.001) after induction in all four groups. The hemodynamic response was similar in all the four groups. There was no significant change in central venous pressure and stroke volume variation (SVV) during induction and intubation, while the effects on the systemic vascular resistance index (SVRI) were variable. The midazolam group was the most effective in preventing intubation stress (tachycardia,hypertension). The change from baseline values in heart rate (&#x002B; 4&#x0025;, <i>P</i> = 0.12) and mean arterial pressure (-1&#x0025;, <i>P</i> = 0.77) after intubation were not statistically significant in the midazolam group. The etomidate group was the least effective of all the four groups in minimizing stress response, with statistically significant increase from baseline in both heart rate (<i>P</i> = 0.001) and mean arterial pressure (<i>P</i> = 0.001) at 1 minute after intubation. All the four anesthetic agents were acceptable for induction in patients with coronary artery disease and left ventricular dysfunction despite a 30 - 40&#x0025; decrease in the cardiac index. Clinician experience along with knowledge of the potential interactions (e.g., premedication, concurrent opioid use) is needed to determine hemodynamic stability during anesthetic induction in these patients with ventricular dysfunction

Mesenteric ischaemia ocurring as a late complication after-aorto-femoral bypass

Patients with coexisting peripheral vascular disease and coronary artery disease constitute a high risk surgical group. Perioperative management of such patients is an anaesthetic challenge. A 57-year-old male presented with critical limb ischaemia and impending gangrene of the right lower limb. Associated coronary artery disease with triple vessel involvement was diagnosed on coronary angiography. This patient underwent an aorto-femoral bypass. The postoperative course was complicated by the development of mesenteric ischaemia requiring emergency laparotomy and bowel resection