Statistical process control methods for quality inspection of blood component samples: a case study / 中国输血杂志

【Objective】 To explore the analytical methods for detecting data in the process of quality inspection of blood component samples. 【Methods】 The quality inspection data of blood component samples from 2018 to 2022 in our center were collected. Based on the principles of statistical process control, control charts were created using Minitab software to analyze key test items. 【Results】 The P control chart was used to analyze the pass rate of platelet content and revealed one out-of-control point. The normality test was performed on plasma protein content to analyze the causes of data fluctuations for further improvement. The mean and range control chart was utilized for hematocrit measurement, with abnormal data trends detected. Further analysis of the normality test and process capability analysis was conducted, resulting in a Cpk value of 0.67. 【Conclusion】 By applying statistical process control methods, the study employed P control charts to analyze count data in the quality inspection of blood component samples, conducted normality tests for measurement data, and utilized mean and range control charts to identify abnormal data trends. For data conforming to a normal distribution, the process capability index (Cpk) was calculated to explore effective monitoring methods for ensuring stability in the blood supply process.

Analysis on Seed Quality Grading Standard of Belamcanda chinensis / 中国实验方剂学杂志

Objective:To study the quality inspection standard of seeds of <italic>Belamcanda chinensis</italic> and establish the quality grading standard of seeds of <italic>B. chinensis</italic>. Method:The purity of seeds of <italic>B. chinensis</italic> from different producing areas was analyzed，and the 1 000-grain weight，water content，viability and germination rate of seeds of <italic>B. chinensis</italic> with different diameters were determined after diameter classification. K-means was used for cluster analysis to preliminarily formulate the quality grading standard of seeds of <italic>B. chinensis</italic>. Result:There were obvious regional differences in the size of seeds of <italic>B. chinensis</italic>. The particle size of seeds of <italic>B. chinensis</italic> of Xiaochang，Dawu and Huanggang Academy of Agricultural Sciences in Hubei Province was larger and mostly between 4.5 mm to 5.5 mm. The seeds of<italic> B. chinensis </italic>from Tuanfeng，Qujing，Yunnan，and Anguo，Hebei province had smaller particle sizes than those from the other three producing areas，which were mostly between 3.5 mm to 5.0 mm. Arils in seeds of <italic>B. chinensis</italic> were removed by 10% NaClO to effectively break seed dormancy and significantly improve the seed germination rate. On this basis，the seed diameter was taken as the main grading index，and the seed moisture content，viability，germination rate and purity were taken as important reference indexes. The quality of seeds of <italic>B. chinensis</italic> was preliminarily divided into three grades，grade Ⅰ：seed diameter≥5.5 mm，moisture content≤10%，viability≥94%，germination rate≥60%，and cleanliness≥93%；grade Ⅱ：seed diameter≥4.5 mm，moisture content≤10%，viability≥90%，germination rate≥55%，and cleanliness≥85%；and grade Ⅲ：seed diameter≥3.5 mm，moisture content≤10%，viability≥84%，germination rate≥45%，cleanliness≥80%. Conclusion:In this study，the quality grading standard of seeds of <italic>B. chinensis</italic> was preliminarily established to provide reference for the quality evaluation of seeds of <italic>B. chinensis</italic> and the breeding of improved varieties. In addition，the maturity and the storage time of seeds of <italic>B. chinensis</italic> have a greater impact on the quality of seeds，so it is recommended to select fully mature（dark black） seeds and new seeds for production.

Management system and development strategy of quality Chinese medicine / 中国中药杂志

The development of quality Chinese medicine is an important way to improve the quality of Chinese medicine, and ensure the safety and effectiveness of Chinese medicine. This article systematically elaborates the definition, classification, standard and mana-gement certification strategy of quality Chinese medicine. We present the quality Chinese medicine which is higher quality than that of eligible Chinese medicine based on quality control standards. Quality Chinese medicine is strictly in accordance with management procedures, likely GAP and GMP et al, during the productive process, which quality indicators is higher than that of the current relevant national quality standards, such as Chinese Pharmacopoeia(ChP) et al; its limited indicators such as exogenous pollutants and endogenous toxic substances are lower than that of the current relevant national quality standards, likely ChP et al; meanwhile these Chinese herbal medicine, medicinal pieces, patent medicines, and health products and foods with Chinese medicine raw materials are been certificated by quality Chinese medicine. At the same time, this article systematically expounds the five major management systems of quality Chinese medicine, including technical training management for practitioners, productive process management, standard mana-gement, quality inspection and certification management, and product traceability management. And we put forward strategies to improve the supervision and management system, and promote the standardization and development of quality Chinese medicine by improving the technical management system of quality Chinese medicine, strengthening the quality management system and six sigma(6σ) management in the company. These strategies will provide a reliable basis and effective way to improve the quality of Chinese medicine.

Research and Application of Quality Inspection Information System in Medical Device Manufacturers / 中国医疗器械杂志

OBJECTIVE@#To improve the production and inspection efficiency of medical device manufacturers, improve the quality system management level of manufacturers, and ensure the safety and effectiveness of medical devices.@*METHODS@#Sort out the business process of the medical device manufacturer, connect the database of production and ERP system to inspection system, and build the operation software for the quality control department.@*RESULTS@#The system has covered all the products of the manufacturer, and has realized the informatization and visualization of the inspection process.@*CONCLUSIONS@#The research and application of the system can improve the quality management traceability system of medical device manufacturers, and improve the efficiency and accuracy of medical device quality inspection.

Analysis of the on-site quality inspection results of occupational medical examination institutions in Guangdong Province in 2020 / 中国职业医学

OBJECTIVE: To analyze the problems existing in the on-site quality inspection of occupational medical examination(OME) institutions in Guangdong Province. METHODS: A total of 96 OME institutions in Guangdong Province were selected as the research subjects using the random number table method. On-site quality inspections were carried out and the results were analyzed. RESULTS: The OME institutions participating in the on-site quality inspection in 2020 accounted for 49.0%(96/196) of total OME institutions in Guangdong Province. Among them, occupational disease prevention and control hospitals/institutions, Centers for Disease Control and Prevention(CDC), public hospitals, and private hospitals accounted for 8.3%, 9.4%, 42.7% and 39.6%, respectively. They were distributed in 17 prefecture-level cities. The registered OME qualifications include dust, chemical factors, physical factors, radiological factors and other categories. Some institutions have registered two or more OME qualifications. The non-qualified rate of the on-site quality inspections in six assessment modules of the 96 OME institutions from high to low were quality management work, equipment(instruments and vehicles) allocation, quality management system, medical and health technical personnel allocation, information report, and on-site professional assessment module, with the non-qualified rate of 24.1%, 22.4%, 20.7%, 15.9%, 15.6% and 1.1% respectively(P<0.01). The problems were mostly concentrated in the CDC, public and private hospitals, and rarely in occupational disease prevention and treatment hospitals/institutes. In addition to the on-site professional assessment module, a total of 696 non-qualified items were detected in the remaining five modules of the 96 OME institutions, with an average of seven items per institution. Occupational disease prevention and treatment hospitals/institutions, CDC, public hospitals, and private hospitals had an average of 2, 9, 8, 7 non-qualified items respectively. CONCLUSION: In the on-site quality assessment of OME institutions in Guangdong Province, there are relatively few problems in all aspects of occupational disease prevention and treatment hospitals/institutes. CDC has certain inadequacies. The public and private hospitals have more prominent problems in aspects of equipment(instruments and vehicles) allocation, quality management system and quality management work.

Measuring Back Injury Risk in Mexican Workers of an Automotive Company / Medición del riesgo de lesión de espalda en trabajadores mexicanos de una empresa automotriz / Medição do risco de lesão de costas em trabalhadores mexicanos de uma empresa automotiva

Abstract Introduction : The Mexican manufacturing sector in the automotive industry employs an average of 8 million 850 thousand workers per year spread across the 32 states, of which Puebla contributes with 465106, developing, in a high percentage, the verification of new parts as part of the manufacture process. This activity is supported by the use of devices known as fixtures, whose equipment and tool forces operators to lift loads between 10 and 50 kilograms by performing manual operations to hold parts, presenting pain at the lumbar level, therefore, it is essential to measure the risks of back injuries in the study population. The objective was to identify and measure the risks of back injuries in the study population. Materials and Methods : The inspection process is analyzed by identifying the potential risk factors. Ergonomic methodologies and instruments are used, such as Quick Exposure Check (QEC), the National Institute for Occupational Safety and Health (NIOSH) equation, the REBA (Rapid Entire Body Assessment) method, Ovako's Work Posture Analysis System (OWAS), among others. Results : The QEC method shows that trunk/back and wrist/hand are the most sensitive parts to risk exposure, indicating that 18 % of the postures are rated 4 in the level of risk, with the back rotated and bent in over 32 % of time. The weight of the operation exceeds 20 kilograms in 71.4 %. Conclusion: Four ergonomic techniques are used to assess the risk of injury, the inspection process of manufactured parts is analyzed.

Resumen Introducción: la industria manufacturera mexicana del ramo automotor emplea en promedio 8 millones 850 mil trabajadores al año repartidos en los 32 estados, de los cuales Puebla contribuye con 465106, desarrollando, en un alto porcentaje, la verificación de piezas nuevas como parte de los procesos de manufactura. Esta actividad se apoya en el uso de dispositivos conocidos como fixtures, cuyo equipo y herramienta obliga a los operarios a levantar cargas entre los 10 y los 50 kilogramos, realizando operaciones manuales para la sujeción de piezas, presentándose dolores a nivel lumbar, por lo que es primordial medir los riesgos de lesiones en la espalda de la población en estudio. El objetivo fue identificar y medir los riesgos de lesiones en la espalda de la población en estudio. Materiales y métodos : se analiza el proceso de inspección identificando los factores de riesgo potencial. Se utilizan metodologías y herramientas ergonómicas, tales como Quick Exposure Check (QEC), la ecuación del National Institute for Occupational Safety and Health (NIOSH), el método REBA (Rapid Entire Body Assessment), el sistema de análisis de posturas de trabajo de Ovako (OWAS), entre otras. Resultados : el método QEC muestra que tronco/ espalda y muñeca/mano son las partes más sensibles a la exposición de riesgo, señalando el 18 % de las posturas en un nivel de riesgo 4, con la espalda rotada y flexionada en más del 32 % del tiempo. El peso que conlleva la operación supera los 20 kilogramos en el 71,4%. Conclusión : se utilizan cuatro técnicas ergonómicas para evaluar el riesgo de lesión y se analiza el proceso de inspección de piezas fabricadas.

Resumo Introdução : a indústria manufatureira mexicana do ramo automotivo emprega em média 8 milhões 850 mil trabalhadores ao ano repartidos nos 32 estados, dos quais Puebla contribui com 465106 deles, desenvolvendo, em uma alta porcentagem a verificação de peças novas como parte dos processos de manufatura. Esta atividade apoia-se no uso de dispositivos conhecidos como fixtures, cuja equipe e ferramentas abriga aos operários a levantar cargas entre os 10 e 50 quilogramas realizando operações manuais para a fixação de peças, se apresentando dores no nível lombar, pelo que é primordial medir os riscos de lesões nas costas da população em estudo. Materiais e métodos : se analisa o processo de inspeção identificando os fatores de risco potencial. Se utilizam metodologias e ferramentas ergonómicas, tais como Quick Exposure Check (QEC), a equação do National Institute for Occupational Safety and Health (NIOSH), o método REBA (Rapid Entire Body Assessment), o sistema de análise de posturas de trabalho de Ovako (OWAS), entre outras. Resultados : o método QEC mostra que o torso/costas e o pulso/mão são as partes mais sensíveis à exposição de risco, assinalando o 18 % das posturas em um nível de risco 4, com as costas rotadas e curvadas em mais do 32 % do tempo. O peso que leva a operação supera os 20 quilogramas no 71.4 %. Conclusão : utilizam-se quatro técnicas ergonómicas para avaliar o risco de lesão e se analisa o processo de inspeção de peças fabricadas.

Design and implementation of an automatic analysis system for magnetic resonance quality detection based on QT / 生物医学工程学杂志

The quality inspection of magnetic resonance imaging (MRI) performance parameters is an important means to ensure the image quality and the reliability of diagnosis results. There are some problems in the manual calculation and eye recognition of the quality inspection parameters, such as strong subjectivity and low efficiency. In view of these facts, an automatic analysis system for MRI quality detection based on QT is proposed and implemented in C++ language. The image processing algorithm is introduced to automatically measure and calculate the quality inspection parameters. The software with comprehensive functions is designed to systematically manage the quality inspection information of MRI. The experimental results show that the automatically calculated parameters are consistent with the manually calculated ones. Accordingly, the accuracy and reliability of the algorithm is verified. The whole system is efficient, convenient and easy to operate, and it can meet the actual needs of MRI quality inspection.

Quality Evaluation of Agencies for Visiting Nurses: Perspectives by Quality Surveyors Employed by the Local Government / 日本プライマリ・ケア連合学会誌

Introduction: This study examined the perspectives of quality surveyors employed by the local government regarding the quality evaluation of agencies for visiting nurses.Methods: The participants were six surveyors. We carried out semi-structured interviews concerning the quality of agencies for visiting nurses. We conducted a qualitative analysis and derived several categories inductively.Results: The surveyors found little difference in the quality between for-profit and non-profit agencies for visiting nurses. In addition, they considered the following characteristics to represent good quality agencies: "availability of home-visit nursing 24 hours per day", "information disclosure and maintenance of quality records", and "the nurse manager understands and promotes an integrated community care system".Conclusion: Eleven categories were identified for the qualitative evaluation of agencies for visiting nurses. The present findings may be used useful for maintaining the quality of agencies for visiting nurses.

Application of big data in medical equipment management / 医疗卫生装备

Objective To apply the big data on medical equipment quality inspection to scientific management of medical equipment.Methods The big data on medical equipment metrological verification and quality control were analyzed,and medical equipment performance curve was drawn based on the function on data standard deviation and time.Results The big data provided support for medical equipment bidding and purchase,preventive maintenance and precision benefit analysis.Conclusion Medical equipment big data is of great significance to enhance medical support ability,and contributes to the management of medical equipment and strategic equipment.

Design and implementation of Magphan-phantom-based image parameters auto evaluation system for MRI quality inspection / 医疗卫生装备

Objective To design and implement an automatic analysis and evaluation system for the image parameters of medical MRI quality testing.Methods The system was developed and debugged by the study on MRI image quality parameters,the image denoising,integration,extraction and etc by MATLAB processing platform as well as the comparison and comparative calculation of the obtained data.Results The system replaced manual operation by auto processing and parameters analysis of MRI quality inspection image.Conclusion The system enhances the efficiency and avoids artificial error,and has a promising prospect in the future.

Design and implementation of Magphan-phantom-based image parameters auto evaluation system for MRI quality inspection / 医疗卫生装备

Objective To design and implement an automatic analysis and evaluation system for the image parameters of medical MRI quality testing.Methods The system was developed and debugged by the study on MRI image quality parameters,the image denoising,integration,extraction and etc by MATLAB processing platform as well as the comparison and comparative calculation of the obtained data.Results The system replaced manual operation by auto processing and parameters analysis of MRI quality inspection image.Conclusion The system enhances the efficiency and avoids artificial error,and has a promising prospect in the future.

Study on content of eucalyptol in chao aiye and aiye tan / 中国生化药物杂志

Objective To improve the quality of aiye processed products, an eucalyptol content in commercially available aiye two processed products of chao aiye and aiye tan was investigated.Methods A capillary gas chromatography was used.The sample was prepared with n-hexane by reflux condensation.Chromatographic conditions: The separation was carried on an Ailgent DB-1 capillary column(30 mm ×0.320 mm ×0.25 μm). Inlet temperature was 200℃ and FID temperature was 250℃.The programmed column temperature was set as follows:maintained at 100℃ for 6 min and raised to 160℃ at the rate of 20℃/min followed by holding for 3min.The splitting-ratio was 5.0:1.The carried gas was nitrogen, flow rate was 1.0 mL/min.Injection volume was 1μL.Results In the given chromatographic conditions, the eucalyptol chromatographic separation had good, and the separation degree was greater than 1.5 between eucalyptol and other impurity peak.The linear range of eucalyptol was 11.4-114.0 mg/mL(r=0.999 5). Methods repeatability and recovery were good.The minimum limit of quantification was 0.5μg/mL.The results of determination of eucalyptol show that the eucalyptol content in the commercially available 11 batch of chao aiye was between 5.6-78.2 μg /g, and 12 batch of aiye tan had no eucalyptol. Conclusion The processing technology of current commercially available aiye processed products of chao aiye and aiye tan need to be improved, and the quality standard need to be improved.

Analysis and Experience of Quality Inspection of TCM Decoction Pieces in Our Hospital / 中国药房

OBJECTIVE:To evaluate the quality of TCM decoction pieces in our hospital preliminarily and explore the solu-tions for the problem of the quality of decoction pieces purchased by the hospital. METHODS:In Jun. 2012,a system was estab-lished by our hospital,where the quality inspector was designated to daily inspect new batches of TCM decoction pieces such as ap-pearance provided by suppliers. The batches of TCM decoction piece samples inspected and those of unqualified products from Jun. 2012 to May 2014 were calculated. The reasons of unqualified products were analyzed and corresponding solutions were made. RE-SULTS&CONCLUSIONS:Over two years,a total of 94 671 batches of TCM decoction piece samples were inspected by our hos-pital,among which 737 were unqualified products predominantly because of mildew,damage by worms,greasing,containing for-eign substances and others. The solutions to such problems included interviewing the suppliers,returning or discontinuing the use of crude drugs and special focus on particular seasons and on the demand for key varieties. The unqualified products rate in the quality inspection reduced from 0.56%in Jun. 2012 to 0.34%in May 2014. Therefore,setting the post of drug quality inspector in the hos-pital can ensure the quality of TCM decoction piece purchased,however,it need to improve the inspection and acceptance of quali-ty inspection by sampling,scoring and using the new technology.

Feasibility of finite element analysis in the application of quality inspection on implantable medical devices / 医用生物力学

For implantable medical devices, traditional mechanical property testing is achieved by mechanical testing devices, while such method is lack of pertinence during sampling of series of products, and also time consuming during experimental testing. With the complete development of finite element analysis (FEA) techniques, introducing FEA to quality supervision and inspection will become a scientific method for saving resources and time, and also improve the pertinence. In this study, the creditability of FEA in application of highest risk sample selection, failure analysis of marketed products and auxiliary optimization of fatigue test testing was verified through case study and experimental testing. The feasibility of FEA during implants inspection was illustrated. In order to ensure the accuracy and reliability of FEA in the application of implants inspection, the essentials of establishing related finite element standards were proposed.

Research on quality inspection technology of medical diagnostic photographic X-ray machine / 医疗卫生装备

The medical diagnostic photographic X-ray machine is a kind of widely used image examination equipment in hospital,and the images produced is of great significance to patients and doctors as an important clinical diagnostic warranty.This paper introduces a quality inspection technology aiming at medical diagnostic X-ray machine in large-scale hospitals.This technology is based on a multipurpose X-ray survey-meter and several performance phantoms.It can survey important parameters and evaluate image quality of X-ray equipments,and is especially fit to clinical engineers to carry out daily quality control.