Concept Of Quality Control Research Articles

Sampling the Food-Processing Environment: Taking Up the Cudgel for Preventive Quality Management in Food Processing (FP).

The Listeria monitoring program for Austrian dairies and cheese factories was established in 1988. The aim was to control the entrance of L. monocytogenes into the food-processing environment (FPE), preventing the contamination of food under processing. The Austrian Listeria monitoring program comprises four levels of investigation, dealing with routine monitoring of samples and consequences of finding a positive sample. Preventive quality control concepts attempt to detect a foodborne hazard along the food-processing chain, prior to food delivery, retailing, and consumption. The implementation of a preventive food safety concept provokes a deepened insight by the manufacturers into problems concerning food safety. The development of preventive quality assurance strategies contributes to the national food safety status and protects public health.

ТЕОРЕТИЧНІ АСПЕКТИ РОЗВИТКУ АУДИТУ НА ОСНОВІ ЯКІСНОГО ПІДХОДУ

The aim of the article is to study the essence of a qualitative approach in auditing and the development of domestic audit based on it in the context of forming a new concept of quality control of audit services in Ukraine. The research methodology is based on theoretical generalizations and the use of scientific tools, including comparative analysis, analysis of the provisions of current legislation of Ukraine and international legislation in the field of audit quality regulation. The research substantiates the assertion that the reform and development of independent audit in Ukraine is based on a qualitative approach as the main direction of improving national legislation in the field of audit and bringing it closer to EU requirements is to improve the quality of audit services and increase confidence in domestic auditors. It is studied that quality management of audit and audit services is to create and operate a quality management system, which aims to create an information product that meets the requirements of standards and can meet the needs of users and ensure their confidence in the reliability of audited financial statements. The analysis of domestic legal requirements for the quality of audit services allows us to state that the main emphasis is placed on ensuring the quality of mandatory audit of financial statements and mandatory audit of financial statements of entities of public interest. As a result of the research, it is proposed to use a qualitative approach in auditing from three interrelated positions: 1) in auditing research – a set of techniques for studying audit objects based on the theory of quality as a historically formed philosophical concept; 2) when conducting an audit and providing audit services – this is a necessary set of tools to ensure the improvement of their quality, which is formed at the international, national and internal levels; 3) in assessing the information provided by the auditor (audit opinion) – the establishment of criteria for its usefulness on the basis of a qualitative approach that allows to establish the level of suitability of information for users.

Discovery and application of traditional Chinese medicine efficacy markers based on systematic traditional Chinese medicine

The quality marker(Q-marker) of traditional Chinese medicine(TCM) is a new concept of TCM quality control proposed in recent years. It is a hot issue in the research of modern Chinese medicine. The TCM efficacy is a high-level summary of the TCM therapeutic effect under the guidance of TCM theory. On this basis, it is of considerable significance to explore the TCM efficacy marker for the TCM modernization. However, the traditional research strategy based on the single herb and decoction piece in macro TCM level, or the drug research strategy based on the biological effect of the targets, is quite different from the characteristics of multiple components of TCM, as well as the weak and low-selective effect of Chinese medicine ingredients on targets. Therefore, how to select representative ingredients to characterize the TCM overall efficacy is a problematic point in establishing TCM efficacy markers. In this paper, the concept and method of Q-marker were introduced into the study of Chinese medicine efficacy. The research method for systematic TCM was used to systematically discuss the connotation of TCM efficacy markers, the principles of discovery and determination, common research ideas and techniques by taking the representative research results as an example. This study provides new ideas for the research and discovery of TCM efficacy markers.

Implementation of the Latest Scientific Knowledge/Technologies and Activities for International Harmonisation of the Japanese Pharmacopoeia

The Japanese Pharmacopoeia (JP) is an official document that defines the specifications, criteria, and standard test methods necessary to properly ensure the quality of medicines in Japan. To ensure the efficacy and safety of pharmaceutical products, it is essential to establish standards that ensure their quality. For this purpose, the JP aims to include all drugs that are important from the viewpoint of healthcare and medical treatment, and description of each monograph of medicine is maintained and improved so that those standards can be generally practiced. In addition, to play a key role as the official document in the field of pharmaceutical product quality, JP contents are enhanced by proactively introducing the latest scientific knowledge and technologies. As the international manufacturing of pharmaceutical products and their raw materials that are distributed in Japan is increasing, the JP has recently begun to promote the international harmonisation of pharmaceutical excipients and general tests through the Pharmacopoeial Discussion Group (PDG) and to swiftly implement the harmonised items in the JP. In addition, the JP will implement internationally harmonised concepts and specifications for pharmaceutical products, e.g., the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), to define the latest concepts of quality control for pharmaceutical products in the official document. We introduce the implementation of the latest scientific knowledge, technologies, and activities for international harmonisation of the JP.

A continued method performance monitoring approach for the determination of pediatric renin samples - application within a European clinical trial.

Background Plasma renin levels were determined in the academia-driven, EU-funded "Labeling of Enalapril from Neonates up to Adolescents" (LENA) project to evaluate its role in pediatric heart failure. Quality-controlled bioanalysis is crucial to ensure reliable data generation. However, a comprehensive bioanalytical quality control (QC) concept to monitor the method performance within an academic environment was lacking. Methods Thus, a QC concept was designed encompassing regulatory guidance, international recommendations and current scientific discussions. The concept included (1) a system-suitability test, (2) verification of single bioanalytical runs by calibration curve performance and evaluation of QCs, (3) assessment of the inter-run accuracy according to Clinical Laboratory Standards Institute (CLSI) guideline, (4) monitoring of reproducibility by pediatric incurred samples, (5) blank-sample analysis and (6) participation in interlaboratory testing. Results The concept was successfully applied to the academic project. About 11% of single runs were identified as invalid and triggered a re-analysis of unknown samples being included in those runs. The usefulness of the customized inter-run monitoring was demonstrated and proved the good accuracy from the first to the last run. All 147 reanalyzed incurred sample pairs complied with regulatory requirements. Conclusions The regulatory complied QC concept was customized for the demands of academia-driven pediatric trials and contributed to the reliable quantification of 965 pediatric renin samples.

Manufacturing and quality assessment of allergenic extracts for immunotherapy: state of the art

The recent developments in the manufacturing and quality assessment of allergenic extracts in Europe are summarized. Quality assessment has always been a fundamental part of allergen product evaluation. New analytical methods have been reported that fill currently existing gaps in the characterization of commonly used allergen products. New types of products require innovative considerations and concepts for their assessment. Advanced standardization efforts aim at increasing reliability and comparability of analytical tools applied for allergen product characterization. In consequence, regulatory requirements are updated in line with such developments. Current demands on the quality of allergen products ensure production of well characterized products of consistent quality. While experience with manufacturing processes and successful product characterization approaches increase, accompanying and continuous re-evaluation of underlying quality control and assessment concepts is being performed.

The development of an herbal material quality control strategy considering the effects of manufacturing processes

BackgroundQuality by design (QbD) is an advanced drug quality control concept that has been gradually implemented in the optimization of manufacturing processes of Chinese medicines. However, the variation of Chinese medicinal material quality has rarely been considered in published works. Because manufacturing processes may lower the variation introduced through different batches of materials, a material quality control strategy should be developed considering the influences of manufacturing processes.MethodsIn this work, the processes of extraction, concentration, water precipitation, and chromatography for notoginseng total saponin (NTS) production were investigated while considering Panax notoginseng quality variation as a sample. Ten process parameters were studied simultaneously using a definitive screening design. After the process critical quality attributes (CQAs) were determined, critical process parameters (CPPs) and critical material attributes (CMAs) were identified simultaneously. Then, models utilizing the CMAs, CPPs, and process CQAs were developed. The design space was then calculated using a Monte Carlo simulation method with an acceptable probability of 0.90. A material quality control strategy considering the influences of manufacturing processes was proposed.ResultsThe ginsenoside Rd purity and total saponin purity in the eluate were identified as process CQAs. The ethanol solution concentration used for extraction, the ethanol solution concentration used for elution, and elution time were identified as CPPs. The extractable dry matter content of Panax notoginseng was one of the CMAs. The extractable contents of notoginsenoside R1, ginsenoside Rg1, ginsenoside Rb1, and ginsenoside Rd were the other CMAs. The inequalities implemented to discriminate the high quality and low quality of Panax notoginseng were developed according to the NTS standard of the Xuesaitong injection. Low quality Panax notoginseng should not be released for NTS production. High quality Panax notoginseng can be treated with feasible manufacturing processing parameters. Verification experiments were carried out successfully for 2 batches of high quality Panax notoginseng.ConclusionsIn this work, a quality control strategy for herbal materials was developed considering the matching of process characteristics and material quality attributes. This strategy is promising for application to other Chinese medicines.

Patient-Based Real-Time Quality Control: Review and Recommendations.

For many years the concept of patient-based quality control (QC) has been discussed and implemented in hematology laboratories; however, the techniques have not been widely implemented in clinical chemistry. This is mainly because of the complexity of this form of QC, as it needs to be optimized for each population and often for each analyte. However, the clear advantages of this form of QC, together with the ongoing realization of the shortcomings of "conventional" QC, have driven a need to provide guidance to laboratories to assist in deploying patient-based QC. This overview describes the components of a patient-based QC system (calculation algorithm, block size, truncation limits, control limits) and the relationship of these to the analyte being controlled. We also discuss the need for patient-based QC system optimization using patient data from the individual testing laboratory to reliably detect systematic errors while ensuring that there are few false alarms. The term patient-based real-time quality control covers many activities that use data from patient samples to detect analytical errors. These activities include the monitoring of patient population parameters such as the mean or median analyte value or using single within-patient changes such as the delta check. In this report, we will restrict the discussion to population-based parameters. This overview is intended to serve as a guide for the implementation of a patient-based QC system. The report does not cover the clinical evaluation of the population.

Research thoughts and methods on grading identification and transmission change law of traditional Chinese medicine(TCM) Q-marker

The quality marker( Q-maker) of traditional Chinese medicine( TCM) has been the core concept of TCM quality evaluation and control in recent years. Based on the knowledge and long-term practice of the researches on TCM quality,we put forward that " Taking the effectiveness as the core,the measurability and peculiarity as necessary conditions,and considering compatibility for TCM formulae,TCM Q-makers are selected and confirmed,and then the transmission and traceability should be investigated as its functional attributes". Selecting the commonly used representative TCM as the research object,based on the score of TCM effectiveness,measurability and peculiarity,a layered three-dimensional integrated technology was adopted for the quantitative evaluation and grading identification of the Q-markers for TCM. And after Q-markers for TCM are selected and confirmed,the transmission variation of the Q-markers is studied in the whole process from the formation of TCM to its function representation. Based on TCM chemical and biological characteristics as well as effectiveness,and integrating multidisciplinary techniques and methods,researches on innovative methods for system identification and confirmation of the TCM Q-makers are developed emphatically to form representative and exemplary extensive application,which will provide significant theoretical and methodological support for effectively improving the quality control level of TCM.

Konsep Pengendalian Mutu Pada Pembuatan Permen Jelly Nenas (Ananas Comosus L.)

In the process of processing jelly candy pineapple requires supervision related to food safety and quality assurance. food quality control is one way to get safe and healthy products according to panelists' requests. The aim is to determine the effect of gelling agent on jelly pineapple candy products, to determine the process of making jelly pineapple candy by applying the concept of quality control, and knowing the level of product preference and quality from organoleptic testing. The method used is quantitative qualitative descriptive where the results of the analysis obtained will be described. The results obtained are gelatin is the best gelling agent in making pineapple jelly candy products. Control control point in the manufacture of jelly pineapple candy is the selection of raw materials, standard weighing material, processing temperature, and drying. The results of chemical analysis of pineapple jelly candy for water content of 15.30%, ash content 0.89%, protein content 1.49%, carbohydrate 82.03%, crude fat 0.79%, fiber 1.25%, and vit C 13.10 mg / 100 g sample. Microbiological analysis, there are 1.3x10-3 colonies / g and E.coli bacteria analysis is <3 APM / g. The results of organoleptic analysis from the level of preference of panelists in pineapple candy are rather like the color, aroma, taste, while liking the texture. The hedonic quality test for pineapple candy is rather not bright yellow in color, chewy and elastic in texture, slightly pineapple-flavored, and sweet. The results of chemical and microbiological analysis are in accordance with SNI for jelly candy, while organoleptic tests require modification to get the best product according to consumer demand.

SISTEM MANAJEMEN MUTU ISO 9001:2015 DI FAKULTAS EKONOMI, UNIVERSITAS NEGERI JAKARTA

Quality Assurance System is a management system to direct and control an organization/institution in determining policies, targets, plans and quality processes/procedures and their continuous achievement. The Faculty of Economics, Jakarta State University (FE-UNJ) is one of the institutions that has implemented the ISO 9001: 2015 standard in Higher Education striving to maintain and maintain the quality improvement consistency in all aspects. The 3 Main Components in Quality Management are: Quality Control, Quality Assurance, Quality Improvement. Management. Quality Management uses controls and guarantees for the product process to achieve quality more consistently. The basic pattern of quality management systems (ISO 9001: 2015) is what we will do and after we write (planning and reporting) and what we write we do is better known as the P-D-C-A pattern (Plan - Do - Check - Action). The concept of quality control is the basis for assessing the results to be achieved in the context of meeting customer needs and satisfaction.

Monitoring and Evaluation Strategies for Quality Control Assurance in Tertiary Educational Institutions in Ebonyi State

This paper examined monitoring and evaluation strategies for quality control assurance in tertiary educational institutions in Ebonyi State. The concepts of monitoring, evaluation, quality control and quality assurance were discussed. Various problems facing monitoring and evaluation as strategies for quality control and quality assurance in tertiary educational institutions in Ebonyi State were also dealt with. The paper examined monitoring and evaluative strategies for improved quality. The study adopted descriptive survey design. Total population of 270 respondents was used in the study. AÂ Â questionnaire instrument was used to collect data for the study with 35 items. The instrument was validated by three experts in the department of Educational Foundations of Ebonyi State University. A reliability index of 0.88 was obtained using cronbach alpha formula. The study was guided by one research question and one null hypothesis. Mean scores were used to answer the research question and t-test was used to analyze the null hypothesis. The study revealed that the 35 suggested strategies were all accepted and the null hypothesis was upheld. The study recommended a total adoption of the 35 strategies by the school management.Â

Standardization system of industry decoction pieces based on whole process quality control concept

Traditional Chinese medicine (TCM) decoction pieces refer to prescription drugs that can be used in clinical or preparation production after processing medicinal herbs. TCM decoction pieces industries are inherited from the culture of TCM and are important because of their independent intellectual property rights. The Chinese Pharmacopoeia (Ch. P) 2010 edition stipulated that "All drugs taken are decoction pieces", which raised the drug status to statutory law for the first time and clearly specified that TCM decoction pieces should be applied to TCM prescription deployment and production of proprietary Chinese medicines. It also pointed out that "The specifications of the decoction pieces used in the preparation should comply with the requirements of the actual process of the corresponding formulation type". For a long time, both the processing methods and the specification grades of the clinically used pieces of Chinese medicine were based on the inheritance and supported by the classical theory and method system centered on TCM processing. However, the theoretical research and specification standards of the decoction pieces used in the production of proprietary Chinese medicines based on modern industry are scarce, and this has led to a series of problems related to the industry, making the processing of decoction pieces becoming a limiting factor in the promotion of the Chinese medicine industry. Aiming at the existing problems of the TCM decoction pieces industry, this article was guided by the standardization system of TCM based on the concept of whole-process quality control, combined with the reference to the Japanese Kampo medicine industry's feeding mode and the reflection on the combination of traditional Chinese medicine processing and modern industry, as well as the study of the core law of the whole-process of TCM production, etc. Industrial decoction pieces and the idea of building a standardized system of TCM industry decoction pieces based on the whole-process quality control were discussed in this paper, which can provide insights for exploring the effective fusion between TCM processing theory and classic heritage and modern manufacturing and can provide the basis for the establishment of a standardized system for industrial decoction pieces based on whole-process quality control of TCM. It can also offer reference for the development of the advantages of geo-authentic crude drug and the establishment of high spots of industry decoction pieces.

Method of Teaching Diagnosis and Improvement Integrating Quality Control Concept

This paper proposes that the method of diagnosing and improving production and quality in the business community is applied to teaching diagnosis and improvement. Let teaching diagnosis and improvement be more concrete and practical rather than formalized in the slogans and words, without knowing how to implement it. And the method proposed in this paper is compared with the eight-step strategy such as knowing how to do, investigating (checking up) the real reasons, analyzing problems, confirming the problems needed to be improved, assuring advance in improvement, understanding the status, modulating the actions, and checking up the method. Results show that there are more concrete practice mode of operation for the method of teaching diagnosis and improvement proposed in this paper. Teaching improvement with the rolling continuous improvement concept makes the teaching quality refinement more sophisticated, perfect and then perfect.

How the Westgard QC Rules Got Their Name: A Personal Recollection.

In the clinical chemistry laboratory of 2018, Westgard QC Rules are widely used and understood by many clinical laboratory scientists and technologists. Many of these same people would be hard-pressed to explain what a Technicon® SMAC™ was. In 1981, the opposite was true. The purpose of this brief note is to describe how the multirule quality control (QC) concepts of Westgard et al. (1) were integrated into a high-speed chemistry analyzer, the Technicon SMAC® II. This integration lead to their popular name, “Westgard QC” and their implementation into routine operation in many clinical laboratories. In the early 1960s, laboratory automation began to change the work flow profile of the clinical laboratory. Automated workstations such as the Technicon AutoAnalyzer™ encouraged the batching of samples by test. By 1967, the first of the multiple analysis chemistry analyzers, the Technicon SMA™ (Sequential Multiple Analysis), enabled the chemistry laboratory to process a single sample to provide 12 different test results at a rate of 30 samples per hour. Consolidation of the laboratory's work flow onto multiple analyzers became the work flow pattern in many clinical settings. The trend was accelerated by the introduction of the Technicon SMAC, (Sequential Multiple Analysis plus Computer) in 1972. This system performed 20 tests on a single serum sample at a sampling rate of 120 samples per hour. Commercial shipments of the system began in 1974. The system …

Using Role-Playing Simulations to Teach Quality Control in the Design of Medical Devices

Abstract – A simulation is used to facilitate cooperative and team-based learning to introduce concepts of human factors, risk analysis, and quality control applied to the design of medical devices. We further use a friendly game-based approach to simulate the dynamics between a customer, a regulatory agency, and competitive manufacturers. Students are divided into manufacturing teams/companies and teaching assistants act as the customer and regulator. To promote positive interdependence and individual accountability, each student within a company is assigned roles of CEO, inspector, marketer, and designer. The goal for each company is to design and produce as many eye patch medical devices as possible, which must be approved by the regulator, within a tight deadline. Products are evaluated by the customer, who decides what price to pay for each unit, at the end of production. The most successful company is determined by the greatest amount of money earned after two rounds of production and sales.

Understanding and implementing of individualized quality control plan

Accurate results in clinical laboratory are extremely important for patient safety. Quality control is the effective method to control the quality of testing process and ensure the patient safety. With the development of detection technology, the concept of quality control has changed. Clinical Laboratory Standards Institute (CLSI) has established a committee to formulate guidelines for quality control plan based on risk management in the laboratory, using the technology of risk management to develop individualized quality control plan. This article will introduce the understanding and practice of individualized quality control plan.(Chin J Lab Med, 2017, 40: 907-910) Key words: Quality control; Individualized medicine; Clinical laboratory techniques; Reference values; Total quality management; Laboratories, hospital

Effect of nursing risk management basing on concept of circulation quality control in decreasing poor incision healing after cesarean section

Objective To explore the effect of nursing risk management basing on concept of circulation quality control in decreasing poor incision healing after cesarean section. Methods Two-hundred puerperae who received cesarean section from September 2014 to August 2016, and whose clinical data were analyzed retrospectively, were divided into risk management group and conventional group according to nursing measures, each with 100 cases. Conventional nursing intervention was conducted to puerperae in the conventional group, while besides that, puerperae in the risk management group were taken care of under the nursing risk management basing on the concept of circulation quality control. Anxiety status of puerperae in the two groups were evaluated, with the self-rating anxiety scale (SAS) , at admission to the hospital, 1 day after intervention, 3 days after intervention and 1 day before leaving hospital. Satisfaction towards nursing was evaluated by a self-designed scale of patients' satisfaction towards nursing in department of gynecology and obstetrics. Incidence of poor incision healing of all puerperae were statistically analyzed. Results Total incidence rate of poor incision healing in the risk management group was 5.00%, lower than 13.00% in the conventional group (χ2=3.91, P<0.05) ; SAS scores of puerperae in the risk management group at 1 day, 3 days after intervention, and 1 day before leaving hospital were significantly lower than that in the conventional group (P<0.05) ; satisfaction towards nursing in the risk management groups was significantly higher than that in the conventional group (P<0.05) . Conclusions Conducting nursing risk management basing on concept of circulation quality control to puerperae after cesarean section can effectively reduce incidence rate of poor incision healing, relieve the patients' bad emotions, and improve their satisfaction towards the nursing care. Key words: Cesarean section; Concept of circulation quality control; Nursing risk management; Poor incision healing; Satisfaction towards nursing

The Role of Total Quality Control (TQC) in the Technical

In the current times, quality is the key word in industries, government and public agencies, often in the concept of total quality or total quality control. The proliferation of Total Quality Control (TQC) has produced a debate. The debate lies between the argument of TQC advocates, who consider it as a distinct and effective method to improve organizational performance, and those who just consider it as another organizational fad. The controversial debate pits TQM advocates against expert scholars who are well-informed of the TQC root methods. More specifically, TQC advocates make use of TQC to develop a position upon which they can scrutinize academic work by failing to examine the concept thoroughly despite the fact that academicians should be able to understand the concept deeply more than advocates, as TQC makes use of technical methods that scholars have been examining for many years. The aim of the present study was to arrive at the common TQC understanding in the technical.

تطبیق مفهوم مراقبة الجودة على مراحل أعمال ترمیم المبانى الأثریة

In general, restoration processes require utmost degree of accuracy and attention when dealing with old buildings of archeological value. This is in order to avoid irreversible damages to the restored parts through its various phases. This paper discusses the possibility of integrating quality control concepts that are usually implemented throughout different construction phases of regular buildings. The restoration experience of Temraz Al- Ahmady Mosque is a selected case study of this research paper; Since such mosque was in need for some sort of inspection during its various stages of its restoration project. The paper debated the issue by dividing the restoration process of the above mosque into three phases: the first phase introduces the project initiation and how the main contractor is selected. The second phase introduces process of selecting the supervising team or the project consultant. The third phase introduces project delivery procedures then followed by an exploration of the possibility of implementing quality control on such phases. إن إعمال الترميم فى مجملها تحتاج الى الدقة والحرص فى الأداء، اذ يجب أن تتوفر الآليات التى تؤمن تضييق مساحة الخطأ الى أقصى حد ممکن عند التعامل مع المبانى الأثرية. تقدم هذه الورقة البحثية مقترحا لضبط مراحل وعمليات الترميم بصفة خاصة، وذلک من خلال تطبيق مفهوم مراقبة الجودة على مراحل الترميم، وقد وقع اختيار البحث على مسجد تمراز الأحمدى کحالة واضحة للدراسة ظهر من خلال التعامل معها ضرورة تطبيق هذا المفهوم أثناء مراحل العمل على ترميمها.