Sunway Medical Laboratory Quality Control Plans Based on Six Sigma, Risk Management and Uncertainty

2017 ◽  
Vol 37 (1) ◽  
pp. 163-176 ◽  
Author(s):  
Jamuna Jairaman ◽  
Zarinah Sakiman ◽  
Lee Suan Li
2020 ◽  
Author(s):  
Daniela Karnutsch ◽  
Francesca Occhipinti ◽  
Daniel Tumiatti ◽  
Thomas Mueller

Abstract Objective The consideration of the principles of risk management in the analytical process is a current trend. The aim of this study was to evaluate whether the risk management index (RMI) for various laboratory parameters can be influenced by interventions that change the internal quality control (IQC) strategy. Methods We selected 10 laboratory parameters associated with cardiovascular disease for the study (myoglobin, N-terminal fragment of the pro B-type natriuretic polypeptide, cardiac troponin T, creatinine kinase, lactate dehydrogenase, glucose, triglycerides, total cholesterol, and low-density lipoprotein and high-density lipoprotein cholesterol). The study-specific interventions included changing the IQC rules and changing the IQC schedule. This was a one-armed intervention study in which changes in the RMI, a measure of patient harm risk, was recorded over time. Results Before the intervention, the mean RMI was 1.022 (95% confidence interval [CI], 0.269–1.776). After the intervention, the mean RMI was 0.934 (95% CI, 0.088–1.956). The RMI values before and after the intervention were not significantly different (P =.89). Conclusion The study-specific interventions did not lead to an improvement of the RMI in the clinical routines of a medical laboratory. There is a great need to further explore this subject area with interventional studies to clarify how the risk of unintended patient harm can be measurably improved.


JEMAP ◽  
2020 ◽  
Vol 3 (1) ◽  
Author(s):  
Albertus Reynaldo Kurniawan ◽  
Bayu Prestianto

Quality control becomes an important key for companies in suppressing the number of defective produced products. Six Sigma is a quality control method that aims to minimize defective products to the lowest point or achieve operational performance with a sigma value of 6 with only yielding 3.4 defective products of 1 million product. Stages of Six Sigma method starts from the DMAIC (Define, Measure, Analyze, Improve and Control) stages that help the company in improving quality and continuous improvement. Based on the results of research on baby clothes products, data in March 2018 the percentage of defective products produced reached 1.4% exceeding 1% tolerance limit, with a Sigma value of 4.14 meaning a possible defect product of 4033.39 opportunities per million products. In the pareto diagram there were 5 types of CTQ (Critical to Quality) such as oblique obras, blobor screen printing, there is a fabric / head cloth code on the final product, hollow fabric / thin fabric fiber, and dirty cloth. The factors caused quality problems such as Manpower, Materials, Environtment, and Machine. Suggestion for consideration of company improvement was continuous improvement on every existing quality problem like in Manpower factor namely improving comprehension, awareness of employees in producing quality product and improve employee's accuracy, Strength Quality Control and give break time. Materials by making the method of cutting the fabric head, the Machine by scheduling machine maintenance and the provision of needle containers at each employees desk sewing and better environtment by installing exhaust fan and renovating the production room.


2019 ◽  
Vol 1 (1) ◽  
pp. 44
Author(s):  
Rony Trizudha ◽  
Sri Rahayuningsih ◽  
Ana Komari

As technology advances at this time, players in business are aware of the importance of product quality in the increasingly fierce competition in the industrial world due to the emergence of many similar companies. Therefore, companies must be able to compete to meet customer desires and try to retain customers. To maintain customers and their marketing areas, companies must have high competitiveness in order to survive by prioritizing quality improvement, increasing efficiency and increasing productivity to improve quality because by increasing quality, products can be accepted among consumers so that company goals can be fulfilled. Therefore, the company must carry out effective quality control which will result in high productivity, lower overall cost of making goods and the factors that cause production failure to be minimized. To improve quality, use the six sigma method, DMAIC and seven tools so that it can be known the cause of the damage and what actions are taken so that there needs to be a controversy to stabilize the processes of the production process so that we can know what percentage of damage and what factors cause damage, therefore there must be measurements and recommendations for improvement and control to reduce the causes From the analysis, it was found that the dent cup was 20.36%, the lid was 21.36% less dense, the lid was damaged in the finished product 18.72%, the cup was 19.28% less thick, the packaging was flexible 20.55%Seiring kemajuan teknologi pada saat ini pelaku di bisnis menyadari akan pentingnya kualitas produk dalam persaingan dunia industri yang semakin ketat karena banyak bermunculan perusahaan-perusahaan sejenis. Oleh sebab itu perusahaan harus dapat bersaing untuk memenuhi keinginan  pelanggan dan berusaha dapat mempertahankan pelanggan. Untuk mempertahankan pelangan dan wilayah pemasaranya perusahaan-perusahaan harus mempunyai daya saing yang tinggi untuk dapat bertahan dengan mengutamakan peningkatan mutu, peningkatan efisiensi dan peningkatan produktivitas untuk meningkatkan kualitas karena dengan peningkatan kualitas, produk dapat diterima di kalangan konsumen sehingga tujuan perusahaan dapat terpenuhi. Maka dari itu perusahaan harus melakukan pengendalian kualitas yang efektif akan menghasilkan produktivitas yang tinggi, biaya pembuatan barang keseluruhan yang lebih  rendah serta  faktor-faktor yang menyebabkan kegagalan produksi akan dapat ditekan sekecil mungkin. Untuk meningkatkan kualitas mengunakan metode six sigma, DMAIC dan seven tools agar dapat diketahui penyebab  kerusakan  dan  tindakan  apa  saja  yang dilakukan sehingga perlu ada kontror untuk menstabilkan  peoses proses produksi sehinga dapat di ketahui berapa persen  kerusakan dan faktor-faktor apa saja yang menyebabkan  kerusakan maka dari itu harus ada pengukuran dan  rekomendasi perbaikan serta melakukan kontrol untuk mengurangi penyebab kerusakan. Dari hasil analisis  di ketahui cup  penyok 20,36%, lid kurang  rapat  21,36%, lid  rusak  pada produk jadi 18,72%,cup kurang tebal 19,28 %kemasan lentur 20,55%


2002 ◽  
Vol 21 (2) ◽  
pp. 97-113 ◽  
Author(s):  
Timothy B. Bell ◽  
Jean C. Bedard ◽  
Karla M. Johnstone ◽  
Edward F. Smith

This paper describes the development and implementation of KRisk, an innovative technology-enabled auditor decision aid for making client acceptance and continuance risk assessments. KRisk, developed and designed by KPMG LLP, is part of the firm's audit quality control and risk management processes. In this paper, we discuss the environmental and technological forces that affect auditor business risk management. We also describe important aspects of the development, functionality, and implementation of KRisk. We discuss possible impediments to realizing the full potential of decision aids that have been reported in prior auditing research, and describe how KRisk and related audit quality control procedures implemented at KPMG were designed to overcome such impediments. Also, we present some ideas for scholarly research dealing with auditor business risk management issues, and issues related to the design and use of decision aids in general.


UNISTEK ◽  
2021 ◽  
Vol 8 (1) ◽  
pp. 6-10
Author(s):  
Egar Naufal Ari Satya ◽  
Wahyudin Wahyudin

Abstrak. Dunia industri yang semakin berkembang akan mengakibatkan banyaknya persaingan. Perus-ahaan yang dapat bersaing adalah perusahaan yang dapat menjaga  kualitas produknya dengan baik sehingga dapat memenuhi kepuasan konsumen. Maka dari itu diperlukan pengendalian kualitas. Penelitian ini difokuskan pada penurunan cacat pada produk batu bata merah di CV. Ghatan Fatahillah dengan metode Six Sigma-DMAIC (Define, Measure, Analyze, Improve, dan Control). Dari hasil penelitian didapatkan DPMO sebesar 36.212 dengan nilai sigma 3,29. Jenis cacat yang paling sering terjadi pada batu bata merah yaitu pecah/patah yaitu sebesar 4.327 atau 59,81% dari total keseluruhan produk yang cacat.  Hasil dari tahap analyze dengan fishbone diagram, ditetapkan penyebab dari pecah/cacat, yaitu: pekerja kurang paham standar kualitas, tidak adanya pemeriksaan produk, pekerja kurang paham prosedur kerja, kinerja mesin tidak stabil, pekerja kurang teliti,  jumlah penggilingan tidak menentu, dan komposisi batu bata tidak menentu. Maka perlu dilakukan usulan perbaikan agar dapat mengurangi jumlah produk yang cacat pada batu bata merah. Kata kunci: DMAIC, DPMO, Pengendalian Kualitas, Six Sigma Abstract. The growing industrial world will result in a lot of competition. Companies that can compete are companies that can maintain the quality of their products well so that they can meet customer satisfaction. Therefore, quality control is needed. This research is focused on reducing defects in red brick products at CV. Ghatan Fatahillah with the Six Sigma-DMAIC method (Define, Measure, Analyze, Improve, and Control). From the research results obtained DPMO of 36,212 with a sigma value of 3.29. The type of defect that most often occurs in red bricks is broken / broken, which is 4,327 or 59.81% of the total defective products. The results of the Analyze stage with the fishbone diagram showed that the causes of breakage / defects were determined, namely: workers do not understand quality standards, lack of product inspection, workers do not understand work procedures, unstable machine performance, workers are not careful, the number of mills is erratic, and composition erratic bricks. So it is necessary to make improvement proposals in order to reduce the number of defective products in red bricks. Keywords: DMAIC, DPMO, Quality Control, Six Sigma


2003 ◽  
Vol 127 (8) ◽  
pp. 978-983 ◽  
Author(s):  
Jacqueline M. Seabrook ◽  
Roger A. Hubbard

Abstract Laboratories contemplating either the addition of new molecular tests or modifying methods approved by the Food and Drug Administration for human papillomavirus testing should be aware of a variety of procedural, performance, and regulatory issues surrounding such activity. Diagnostic medical laboratory testing in the United States is regulated by the Centers for Medicare and Medicaid Services, an agency formerly known as the Health Care Finance Administration. The regulatory vehicle of the Centers for Medicare and Medicaid Services is manifested in the Clinical Laboratory Improvement Amendments (CLIA). The CLIA program has put into place specific regulations for laboratory quality control, which includes specific recommendations for method validation. Regulations that must be followed regarding personnel, quality control, quality assurance, method validation, and proficiency testing depend on the complexity category of the individual test. All molecular diagnostic tests, including those for human papillomavirus, are considered high complexity. The Centers for Medicare and Medicaid Services retains the authority to allow private, national accreditation organizations to “deem” that a laboratory is compliant with CLIA '88 requirements. Accreditation organizations, such as the Joint Commission for Accreditation of Hospitals, the Commission on Office Laboratory Accreditation, and the College of American Pathologists (CAP), as well as several state medical laboratory–accrediting agencies, possess the authority to deem laboratories as “CLIA-approved.” The CAP, through its Laboratory Accreditation Program, has promoted standards for laboratory performance and method validation. In general, guidelines set forth in the CAP Laboratory Accreditation Program checklists specify that all clinical laboratory testing must essentially meet those requirements defined for high-complexity testing under CLIA '88, including test validation standards, reportable/reference ranges, performance criteria, and proficiency testing.


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