Revision of Viable Environmental Monitoring in a Development Pilot Plant Based on Quality Risk Assessment: A Case Study

2017 ◽  
Vol 71 (3) ◽  
pp. 234-244
Author(s):  
Ildikó Ziegler ◽  
Judit Borbély-Jakab ◽  
Lilla Sugó ◽  
Réka J. Kovács
Keyword(s):  
Risk Assessment ◽  
Environmental Monitoring ◽  
Pilot Plant ◽  
Quality Risk

scholarly journals Use of Hazard Analysis Critical Control Point (HACCP) methodology for biocontamination control: Assessing microbial risks and to determining environmental monitoring locations

2019 ◽  
Author(s):  
Tim Sandle ◽  
Clare Leavy ◽  
Monica Di Mattia
Keyword(s):  
Risk Assessment ◽  
Environmental Monitoring ◽  
Assessment Tool ◽  
Hazard Analysis ◽  
Essential Feature ◽  
Control Point ◽  
Sterility Testing ◽  
Critical Control Point ◽  
Critical Control Points

Quality Risk Management has been an essential feature relating to the manufacture of pharmaceutical and healthcare products for several decades, and its centrality is embedded in key regulatory documents, such as Annex 1 to EU GMP where risk assessment needs to be part of the overall biocontamination control strategy. While the message for constructing pro-active risk assessment sis clear, where the industry lacks direction is with case studies. This paper presents one risk assessment tool, and one which is perhaps best suited to microbiological assessments of pharmaceutical processes and presents a case study for its application. The tool discussed is Hazard Analysis and Critical Control Points (HACCP) and the application is with assessing microbiological risks and then establishing locations for environmental monitoring. The case study is a sterility testing isolator. The paper first discusses what HACCP is and how it can be applied in general, before demonstrating how HACCP can be deployed as a robust tool for constructing or reviewing an environmental monitoring regime.

An Overview of Risk-Based EEE Counterfeit Part Detection Based on SAE AS6171

2018 ◽  
Author(s):  
Michael H. Azarian
Keyword(s):  
Risk Assessment ◽  
Multiple Solutions ◽  
Test Equipment ◽  
Assessment Methodology ◽  
Test Plan ◽  
Specific Test ◽  
Risk Assessment Methodology

Abstract As counterfeiting techniques and processes grow in sophistication, the methods needed to detect these parts must keep pace. This has the unfortunate effect of raising the costs associated with managing this risk. In order to ensure that the resources devoted to counterfeit detection are commensurate with the potential effects and likelihood of counterfeit part usage in a particular application, a risk based methodology has been adopted for testing of electrical, electronic, and electromechanical (EEE) parts by the SAE AS6171 set of standards. This paper provides an overview of the risk assessment methodology employed within AS6171 to determine the testing that should be utilized to manage the risk associated with the use of a part. A scenario is constructed as a case study to illustrate how multiple solutions exist to address the risk for a particular situation, and the choice of any specific test plan can be made on the basis of practical considerations, such as cost, time, or the availability of particular test equipment.

Accounting for Uncertainty in Risk Assessment: Case Study of Hector's Dolphin Mortality due to Gillnet Entanglement

2000 ◽  
Vol 14 (5) ◽  
pp. 1264-1270 ◽  
Author(s):  
Elisabeth Slooten ◽  
David Fletcher ◽  
Barbara L. Taylor
Keyword(s):  
Risk Assessment

Storm surge risk assessment method for a coastal county in China: case study of Jinshan District, Shanghai

2020 ◽  
Vol 34 (5) ◽  
pp. 627-640 ◽  
Author(s):  
Shi Xianwu ◽  
Qiu Jufei ◽  
Chen Bingrui ◽  
Zhang Xiaojie ◽  
Guo Haoshuang ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Storm Surge ◽  
Assessment Method ◽  
Risk Assessment Method ◽  
Coastal County

scholarly journals A Framework for Project Risk Assessment in Dynamic Networks: A Case Study of Oil and Gas Megaproject Construction

IEEE Access ◽  
2021 ◽  
pp. 1-1
Author(s):  
Amir Farmahini Farahani ◽  
Kaveh Khalili-Damghani ◽  
Hosein Didehkhani ◽  
Amir Homayoun Sarfaraz ◽  
Mehdi Hajirezaie
Keyword(s):  
Risk Assessment ◽  
Oil And Gas ◽  
Dynamic Networks ◽  
Project Risk ◽  
Project Risk Assessment
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