scholarly journals ISO 17025: Practical Benefits of Implementing a Quality System

2003 ◽  
Vol 86 (5) ◽  
pp. 1038-1044 ◽  
Author(s):  
Julie D Honsa ◽  
Deborah A McIntyre
Keyword(s):  
Method Development ◽  
Monitoring Program ◽  
Daily Basis ◽  
Quality System ◽  
Preventive Action ◽  
Quality Improvements ◽  
Iso 17025 ◽  
Management Quality ◽  
Technical Requirements ◽  
Maintenance Program

Abstract As a laboratory certified to ISO 9001:2000 and accredited to ISO 17025, rtech laboratories has incorporated an overall system for technical and quality management, which results in benefits observed in daily laboratory practices. Technical requirements were updated to include the addition of formal personnel training plans and detailed records, method development and validation procedures, measurement of method uncertainty, and a defined equipment calibration and maintenance program. In addition, a stronger definition of the sample preparation process was documented to maintain consistency in sampling, and a more rigorous quality control monitoring program was implemented for chemistry and microbiology. Management quality improvements focused on document control to maintain consistent analytical processes, improved monitoring of supplier performance, a contract review process for documenting customer requirements, and a system for handling customer comments and complaints, with continuous improvement through corrective and preventive action procedures and audits. Quarterly management review of corrective actions, nonconforming testing, and proficiency testing aid in determining long-term trending. The practical benefits of these technical and management quality improvements are seen on a daily basis in the laboratory. Faster identification and resolution of issues regarding methods, personnel or equipment, improved customer satisfaction, meeting quality requirements of specialized customers, and overall increased laboratory business are all the result of implementing an effective quality system.

scholarly journals Analytical Method Development and Validation for the Quantification of Acetone and Isopropyl Alcohol in the Tartaric Acid Base Pellets of Dipyridamole Modified Release Capsules by Using Headspace Gas Chromatographic Technique

2018 ◽  
Vol 2018 ◽  
pp. 1-10 ◽  
Author(s):  
Sriram Valavala ◽  
Nareshvarma Seelam ◽  
Subbaiah Tondepu ◽  
V. Shanmukha Kumar Jagarlapudi ◽  
Vivekanandan Sundarmurthy
Keyword(s):  
Tartaric Acid ◽  
Method Development ◽  
Isopropyl Alcohol ◽  
Fused Silica ◽  
Chromatographic Technique ◽  
Modified Release ◽  
Flame Ionization ◽  
Technical Requirements ◽  
Headspace Gas ◽  
Gas Chromatographic Method

A simple, sensitive, accurate, robust headspace gas chromatographic method was developed for the quantitative determination of acetone and isopropyl alcohol in tartaric acid-based pellets of dipyridamole modified release capsules. The residual solvents acetone and isopropyl alcohol were used in the manufacturing process of the tartaric acid-based pellets of dipyridamole modified release capsules by considering the solubility of the dipyridamole and excipients in the different manufacturing stages. The method was developed and optimized by using fused silica DB-624 (30 m × 0.32 mm × 1.8 µm) column with the flame ionization detector. The method validation was carried out with regard to the guidelines for validation of analytical procedures Q2 demanded by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). All the validation characteristics were meeting the acceptance criteria. Hence, the developed and validated method can be applied for the intended routine analysis.

ISO 17025 quality system in a university environment

2005 ◽  
Vol 10 (7) ◽  
pp. 369-372 ◽  
Author(s):  
Ako Rodima ◽  
Martin Vilbaste ◽  
Olev Saks ◽  
Erko Jakobson ◽  
Eve Koort ◽  
...  
Keyword(s):  
Quality System ◽  
Iso 17025 ◽  
University Environment

scholarly journals The Effectiveness of the Transaction Systems on the Dax Index

2020 ◽  
Vol 4 (28) ◽  
pp. 149-174
Author(s):  
Marek Trembiński ◽  
Joanna Stawska
Keyword(s):  
Portfolio Management ◽  
Stock Exchange ◽  
Technical Analysis ◽  
Quality Measures ◽  
Daily Basis ◽  
Significant Loss ◽  
Investment Strategies ◽  
Trading Systems ◽  
Management Quality ◽  
Analysis Tools

The purpose of the article/hypothesis: The aim of this article is to examine the effectiveness of trading systems built on the basis of technical analysis tools in 2015–2020 on the DAX stock exchange index. Efficiency is understood as generating positive rates of return, taking into account the risk incurred by the investor, as well as achieving better results than passive strategies. Presenting empirical evidence implying the value of technical analysis is a difficult task not only because of a huge number of instruments used on a daily basis, but also due to their almost unlimited possibility to modify parameters and often subjective evaluation.Methodology: The effectiveness of technical analysis tools was tested using selected investment strategies based on oscillators and indicators following the trend. All transactions were carried out on the Meta Trader 4 platform. The analyzed strategies were comprehensively assessed using the portfolio management quality measures, such as the Sharpe measure or the MAR ratio (Managed Account Ratio).Results of the research: The test results confirmed that the application of described investment strategies contributes to the achievement of effective results and, above all, protects the portfolio against a significant loss in the period of strong turmoil on the stock exchange. During the research period, only two strategies (Ichimoku and ETF- Exchange traded fund) would produce negative returns at the worst possible end of the investment. At the best moment, however, the „passive” investment achieved the lowest result. Looking at the final balance at the end of 2019, as many as four systems based on technical analysis were more effective than the „buy and hold” strategy, and at the end of the first quarter of 2020 – all of them. When analyzing the management quality measures, it turned out that taking into account the 21 quarters, the passive strategy had the lowest MAR index. The Sharpe’s measure is also relatively weak compared to the four leading strategies.

scholarly journals Influence of industrial accidents in defense industry on security in the Republic of Serbia

2021 ◽  
Vol 6 (1) ◽  
pp. 55-62
Author(s):  
Rade Slavković ◽  
Aleksandar Dumić ◽  
Marko Gnjatović
Keyword(s):  
Defense Industry ◽  
Daily Basis ◽  
Point Of View ◽  
Security Risk ◽  
Preventive Action ◽  
Industrial Accidents ◽  
Safety Level ◽  
Scarce Resources ◽  
Hazardous Gases ◽  
The Republic

The security of people and property is one of the basic premises of the business of each company. Security as an important function of management of the organization, particularly evident in companies engaged in the production of explosives and flammable substances. In the category of security risk companies are the defense industry companies. Recently, these findings have been confirmed through several industrial accidents with serious consequences. Security vulnerability of these companies is reflected primarily in the sensitivity of certain production and technological processes in terms of exposure to destructive influences and possible occurrence of fire, explosion of a hazardous gases and liquids. Reasons for increased surveillance and a higher safety level can be found in the volume and sensitivity of explosives and flammable substances on a daily basis participate in the processes of production. Considering aforementioned clearly imposes the task of preventive action and preventing accidents and diminishes the effects of their possible manifestation (if they occur). This paper considers the most characteristic of industrial accidents that have occurred in the defense industry from the point of view of their phenomenological characteristics, with a view to identifying the causes of these phenomena and take measures to correct them, in order to prevent repeated and similar events. As the most relevant, addressed the issues of prevention of accidents and safety activities of operators in terms of prevention and elimination of consequences. Also, paper presents singled out the conclusions derived by treating these very complex and in modern times most of the current problems, which requires the full attention of all security subjects in the country, in order to prevent extremely dangerous and even disastrous consequences for security facilities in the Republic of Serbia and the destruction of valuable and scarce resources.

scholarly journals Dinophysis Species and Diarrhetic Shellfish Toxins: 20 Years of Monitoring Program in Andalusia, South of Spain

Toxins ◽  
2019 ◽  
Vol 11 (4) ◽  
pp. 189 ◽  
Author(s):  
Raúl Fernández ◽  
Luz Mamán ◽  
David Jaén ◽  
Lourdes Fernández Fuentes ◽  
M. Asunción Ocaña ◽  
...  
Keyword(s):  
Time Series ◽  
Time Series Data ◽  
Monitoring Program ◽  
Early Spring ◽  
Series Data ◽  
Potential Health ◽  
Iso 17025 ◽  
Toxic Phytoplankton ◽  
Shellfish Toxins ◽  
Diarrhetic Shellfish Toxins

In Andalusia, the official monitoring program for toxic phytoplankton and marine biotoxins was launched in 1994 to comply with European legislation. Since then, there have been numerous episodes of DST (Diarrhetic shellfish toxins) associated with the proliferation of Dinophysis species. This article reviews two decades of time series data and assesses the effectiveness of the program established. The testing of lipophilic toxins and toxic phytoplankton is based on official methods harmonized and accredited since 2007 according to the standard UNE-EN-ISO 17025. The major species of Dinophysis identified were D. acuminata complex, D. caudata, D. acuta and D. fortii, with the main growth season being from early spring until the end of autumn. Both D. acuminata complex and D. acuta have been clearly associated with toxicity in molluscs. Despite the complexity of data obtained through monitoring programs, it is possible to provide early warning of potential health risks for most situations. This is the first report of Dinophysis species and their relation to DST events in a time series from Andalusia.

scholarly journals Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics

2015 ◽  
Vol 2015 ◽  
pp. 1-9 ◽  
Author(s):  
Ramalingam Peraman ◽  
Kalva Bhadraya ◽  
Yiragamreddy Padmanabha Reddy
Keyword(s):  
Analytical Method ◽  
Method Development ◽  
Quality By Design ◽  
Current Trend ◽  
Quality System ◽  
Analytical Quality ◽  
Pharmaceutical Quality ◽  
Pharmaceutical Quality System ◽  
Methods Analytical ◽  
Regulatory Flexibility

Very recently, Food and Drug Administration (FDA) has approved a few new drug applications (NDA) with regulatory flexibility for quality by design (QbD) based analytical approach. The concept of QbD applied to analytical method development is known now as AQbD (analytical quality by design). It allows the analytical method for movement within method operable design region (MODR). Unlike current methods, analytical method developed using analytical quality by design (AQbD) approach reduces the number of out-of-trend (OOT) results and out-of-specification (OOS) results due to the robustness of the method within the region. It is a current trend among pharmaceutical industry to implement analytical quality by design (AQbD) in method development process as a part of risk management, pharmaceutical development, and pharmaceutical quality system (ICH Q10). Owing to the lack explanatory reviews, this paper has been communicated to discuss different views of analytical scientists about implementation of AQbD in pharmaceutical quality system and also to correlate with product quality by design and pharmaceutical analytical technology (PAT).

scholarly journals Audits

2021 ◽  
pp. 25-34
Author(s):  
Olga López-Villar ◽  
Julie Dolva
Keyword(s):  
Corrective Action ◽  
Quality System ◽  
Preventive Action ◽  
Process Improvements ◽  
Essential Components ◽  
Selection Of

AbstractThere are different tools to measure the efficacy of the quality system and of its processes. Among them, internal audits are essential components since they cover all aspects of the program. Auditing is a systematic and documented process to ensure compliance with requirements. Preparing and planning are important parts of a good audit and the selection of the auditor must be based on expertise and competency. The appropriate analysis of the results of the audit and implementation of the corrective action, preventive action, or process improvements after the audit will help the program to improve year after year.

Sign in / Sign up

Export Citation Format

Share Document