Tools for products and services quality control and management in the implementation of ISO 13485:2016 in the company for the production of medical devices to ensure product quality

Author(s):  
P.A. Lontsikh ◽  
◽  
O.V. Maximova ◽  
L.I. Tatarnikova ◽  
I.I. Livshits ◽  
...  
Author(s):  
Genbao Zhang ◽  
Yan Ran ◽  
Dongmei Luo

Supply chain quality is the assurance of product quality in its full life-cycle. Although supply chain quality control is a hot topic among researchers, supply chain quality prediction is actually an important but unsolved problem in manufacturing industry. In this paper, an approach of manufacturing supply chain quality prediction based on quality satisfaction degree is proposed to control supply chain better, in order to help ensure product quality. Supply chain quality prediction 3D model and model based on customer satisfaction and process control are established firstly. And then technologies used in quality prediction are studied, including quality prediction index system established on Expert scoring -AHP and prediction workflow built on ABPM. Finally an example is given to illustrate this approach. The customer satisfaction prediction result of supply chain quality can help supply chain management, and the quality prediction software system can make it easier, which provides a new direction for the product quality control technology research.


Author(s):  
Genbao Zhang ◽  
Yan Ran ◽  
Dongmei Luo

Supply chain quality is the assurance of product quality in its full life-cycle. Although supply chain quality control is a hot topic among researchers, supply chain quality prediction is actually an important but unsolved problem in manufacturing industry. In this paper, an approach of manufacturing supply chain quality prediction based on quality satisfaction degree is proposed to control supply chain better, in order to help ensure product quality. Supply chain quality prediction 3D model and model based on customer satisfaction and process control are established firstly. And then technologies used in quality prediction are studied, including quality prediction index system established on Expert scoring -AHP and prediction workflow built on ABPM. Finally an example is given to illustrate this approach. The customer satisfaction prediction result of supply chain quality can help supply chain management, and the quality prediction software system can make it easier, which provides a new direction for the product quality control technology research.


2004 ◽  
Vol 47 (1) ◽  
pp. 111-115 ◽  
Author(s):  
Otmar Schmid ◽  
Max Trueblood ◽  
Donald Hagen ◽  
Philip Whitefield

Numerous manufacturing processes require extremely low levels of nanoparticulate contamination to ensure product quality. While modern filters efficiently remove nanoparticles, online monitoring of the cleanliness of possibly reactive process gases is frequently necessary for quality control purposes. For most manufacturing processes, product quality depends on the concentration of particles above a specific threshold size. This paper will describe how to design an online nanoparticle monitoring system (NMS) for reactive (and inert) process gases from commercially available components, and will discuss how to adapt this system to varying process requirements, such as particle threshold size, and type and pressure of process gas. This paper will also describe a method to determine experimentally the performance of an NMS to ensure quality control.


2011 ◽  
Vol 314-316 ◽  
pp. 2524-2528
Author(s):  
Guang Hui Zhou ◽  
Ben Wang ◽  
Zhong Dong Xiao ◽  
Ping Yu Jiang

In the 6σ-based product quality management system, influencing factors of 5M1E (man, machine, material, method, measure and environment) are the key points to ensure the quality of products reach 6σ level. However, because the traditional quality control methods only focus on the factors of machine, material, method and measure but ignore the factors of man and environment and their relationship on product quality, the 6σ level objective of product quality cannot be implemented well. As such, this study proposes an improving approach for 6σ-based multi-process machining environment whose objective is to build the connection relationship and model among operating environment, workers and product quality. Through adjusting the values of operating environmental parameters, the behaviors of workers on machines can be controlled and the product quality can be improved. This study provides a new solution for 6σ-based product quality control and management.


2017 ◽  
Vol 17 (6) ◽  
pp. 13-24
Author(s):  
E.V. Freydina ◽  
◽  
E.V. Freydina ◽  
A.A. Botvinnik ◽  
A.N. Dvornikova ◽  
...  

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%


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