An Approach to Development of Manufacturing Data Report According to International Standards

2018 ◽  
Vol 879 ◽  
pp. 248-253
Author(s):  
Papatsorn Singhatham ◽  
Chokchai Singhatham ◽  
Niphaporn Panya ◽  
Salakchit Pukjaroon
Keyword(s):  
Quality Control ◽  
Quality Assurance ◽  
Petrochemical Industry ◽  
Industrial Sector ◽  
International Standards ◽  
Maintenance Management ◽  
Clear Pattern ◽  
Standard Format ◽  
Equipment Operation ◽  
American Society

The research purposes to design, analyze and build a report (MDR) integrity. To use as the MDR prototype in accordance with international standards for industrial factories. The MDR is important to the operator of equipment, the factories, and petrochemical industry because of it is an index for the quality assurance, quality control of fabrication and planning of maintenance management (material upgrade/ equipment change) for safety during equipment operation. When the equipment has a problem we can check for cause from the fabrication history data on MDR. A survey was developed for people concerned with the MDR, totaling 141 people from 58 factories in Thailand industrial sector for find out the demands and problems on using the MDR. The result shows that preparation of the MDR can cost more than a week of time, with no clear pattern of standard format and require manpower more than 3 peoples. In summary, the development of the MDR prototype by comparative data between, the manufacturer, the Ministry of Industry of Thailand and the American Society of Mechanical Engineers (ASME). The specialists who have the experience in the MDR to determine the completeness and validate all content in the MDR 15 chapters.

Quality Assurance in the Analytical Chemistry Laboratory

2007 ◽  
Author(s):  
D. Brynn Hibbert
Keyword(s):  
Analytical Chemistry ◽  
Quality Control ◽  
Quality Assurance ◽  
Metrological Traceability ◽  
International Standards ◽  
Chemistry Laboratory ◽  
Iso 17025 ◽  
Control Procedures ◽  
Analytical Services ◽  
The Right

Analytical chemical results touch everyones lives can we eat the food? do I have a disease? did the defendant leave his DNA at the crime scene? should I invest in that gold mine? When a chemist measures something how do we know that the result is appropriate? What is fit for purpose in the context of analytical chemistry? Many manufacturing and service companies have embraced traditional statistical approaches to quality assurance, and these have been adopted by analytical chemistry laboratories. However the right chemical answer is never known, so there is not a direct parallel with the manufacture of ball bearings which can be measured and assessed. The customer of the analytical services relies on the quality assurance and quality control procedures adopted by the laboratory. It is the totality of the QA effort, perhaps first brought together in this text, that gives the customer confidence in the result. QA in the Analytical Chemistry Laboratory takes the reader through all aspects of QA, from the statistical basics and quality control tools to becoming accredited to international standards. The latest understanding of concepts such as measurement uncertainty and metrological traceability are explained for a working chemist or her client. How to design experiments to optimize an analytical process is included, together with the necessary statistics to analyze the results. All numerical manipulation and examples are given as Microsoft Excel spreadsheets that can be implemented on any personal computer. Different kinds of interlaboratory studies are explained, and how a laboratory is judged in proficiency testing schemes is described. Accreditation to ISO 17025 or OECD GLP is nearly obligatory for laboratories of any pretension to quality. Here the reader will find an introduction to the requirements and philosophy of accreditation. Whether completing a degree course in chemistry or working in a busy analytical laboratory, this book is a single source for an introduction into quality assurance.

scholarly journals Quality assurance of genetic laboratories and the EBTNA practice certification, a simple standardization assurance system for a laboratory network

2018 ◽  
Vol 2 (4) ◽  
pp. 215-222
Author(s):  
Vincenza Precone ◽  
Munis Dundar ◽  
Tommaso Beccari ◽  
Eda Tahir Turanli ◽  
Stefano Cecchin ◽  
...  
Keyword(s):  
Quality Control ◽  
Quality Assurance ◽  
International Standards ◽  
National Standards ◽  
Internal Quality ◽  
Quality Assurance System ◽  
Delayed Treatment ◽  
Assurance System ◽  
Laboratory Results ◽  
International Standards Organization

Abstract Analytical laboratory results greatly influence medical diagnosis, about 70% of medical decisions are based on laboratory results. Quality assurance and quality control are designed to detect and correct errors in a laboratory’s analytical process to ensure both the reliability and accuracy of test results. Unreliable performance can result in misdiagnosis and delayed treatment. Furthermore, improved quality guarantees increased productivity at a lower cost. Quality assurance programmes include internal quality control, external quality assessment, proficiency surveillance and standardization. It is necessary to try to ensure compliance with the requirements of the standards at all levels of the process. The sources of these standards are the International Standards Organization (ISO), national standards bodies, guidelines from professional organisations, accreditation bodies and governmental regulations. Laboratory networks increase the performance of laboratories in support of diagnostic screening programme. It is essential that genetic laboratories of a network have procedures underpinned by a robust quality assurance system to minimize errors and to reassure the clinicians and the patients that international standards are being met. This article provides an overview of the bases of quality assurance and its importance in genetic tests and it reports the EBTNA quality assurance system which is a clear and simple system available for access to adequate standardization of a genetic laboratory’s network.

scholarly journals OVERVIEW ABOUT PROJECT QUALITY MANAGEMENT

2013 ◽  
Author(s):  
Catalin Drob
Keyword(s):  
Quality Control ◽  
Quality Assurance ◽  
Quality Management ◽  
International Standards ◽  
Quality Planning ◽  
Project Quality ◽  
Management Quality ◽  
Project Management Institute ◽  
Prince Method ◽  
Comparative Manner

The purpose of this study is to emphasize the main aspects regarding project quality management. This study tries to present in the comparative manner, different approaches of the main guidelines, international standards and methodologies regarding project quality management (the PMBOK ® Guide elaborated by the Project Management Institute, the PRINCE method elaborated by the British Office of Government Commerce etc.). The PMBOK® Guide describes three elements (processes) of quality management: quality planning (plan quality management), quality assurance (perform quality assurance) and quality control (control quality). The PMBOK approach regarding project quality management is that quality management must lead to achieving and validating project requirements. According the PRINCE method the quality is one of the six variables involved in any project. The PRINCE approach regarding project quality management considers that strategy in this field must lead to achieving just the level of quality needed to achieve in the project and not to ensuring the best quality.

scholarly journals Challenges in meeting patient assessment international standards in ambulatory tuberculosis services

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
L A Aslanyan ◽  
N T Truzyan
Keyword(s):  
Quality Control ◽  
Radiation Safety ◽  
Safety Management ◽  
Management Program ◽  
International Standards ◽  
Capital City ◽  
Diagnostic Tools ◽  
Patient Assessment ◽  
Safety Program ◽  
Environmental Controls

Abstract Background Limitations of tuberculosis (TB) diagnostic tools and measures restrict proper TB control in places with high drug-resistant TB prevalence. This study aimed to explore gaps in the primary health care (PHC) TB services in Armenia compared to international standards on Assessment of Patients (AOP). Methods We applied mixed methods to assess the AOP standards in 30 outpatient TB centers using observational and documents/medical records review's standardized checklists, in-depth interviews, and focus group discussions. Evaluation was conducted in all 10 regions of Armenia and the capital city Yerevan. Joint Commission International Standards for Ambulatory Care, International Standards for TB Care, and WHO framework, served as a guideline for this assessment. Results PHC physicians are qualified for a set of examinations to diagnose TB. Planned reassessments are conducted continuously, though defined writings for the scope and content of reassessments administered by each clinical discipline is absent. Laboratory departments provide high quality services to the TB patients with the defined timeframes for reporting the results. Laboratory and radiology services staff is qualified and experienced. The biosafety rules are compliant with local and international standards. However, the location and conditions of the laboratory departments are mostly non-compliant with the standards. Lack of modern equipment restricts maintaining proper environmental controls, including ventilation systems. Laboratory technicians have little knowledge of the organization's safety management program and its relation to the laboratory safety program. The facilities have neither formal quality control programs regulated by documents and policies nor an identified radiation safety program protocol. Conclusions On the level of AOP standards, the PHC TB services in Armenia have satisfactory performance. However, assessed standards for this function required certain improvements. Key messages In Armenia, the tuberculosis care in PHC facilities presents high level of compliance for patient assessment international standards. To fully meet the standards, facilities need to reconstructed/renovated laboratories and establish the radiology and diagnostic equipment management, quality control and radiation safety programs.

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