China
Africa
Explore chapters and articles related to this topic
Project Risk Management Planning
Published in Davies A. Igberaese, Introduction to Project Management, 2023
Risks are an inherent part of projects, because projects by nature involve a lot of uncertainties. Risks occur from the outset of a project through the entirety of the project lifecycle. This Risk Management Plan is an effective framework that documents how risks on the project would be proactively and reactively managed throughout the project lifecycle. The overall objective of the Project Risk Management Plan is to identify and mitigate negative risks before they have any chance of having negative impacts on the project. It is also intended to maximize the positive impacts of any positive risk arising from the project. The Risk Management Plan describes the Risk Management Activities, the procedures and schedules for performing these activities, requirements for documenting and reporting these activities, and personnel/organization with responsibilities for performing specific risk-related activities or duties.
Operating Wisely
Published in Carl Bozzuto, Boiler Operator's Handbook, 2021
Preparing disaster plans has taken on increased significance since a number of major accidents or storms have caused considerable and costly damage. A risk management plan is a document that a manager prepares to foresee risks, estimate impacts, and define responses to those risks. It also contains a risk assessment matrix. A risk is an uncertain event or condition that, if it occurs, has a negative effect. The EPA and OSHA are coordinating their efforts to update the requirements under the Risk Management Program Development Rule. Elements include emergency response, incident reporting, third-party audits, record keeping, drills, and training/certification. Risk, or disaster, plans should be carried out in a similar manner to SOPs for new installations. Consider what would have to be done in the event of a disaster. Preparing for such events is a wise action.
Principles of Quality Management
Published in Alan J. Stolzer, Carl D. Halford, John J. Goglia, Safety Management Systems in Aviation, 2018
Alan J. Stolzer, Carl D. Halford, John J. Goglia
Prudent project managers will develop a risk management plan for their projects. A risk management plan attempts to proactively identify the risks, assess the risks, develop a response to the risks, and control the risk response. This may include the provision of contingency funds. The key to an effective risk management plan is to do this planning proactively when time, cost, and an array of technical solutions are at the disposal of the project manager.
Regulatory considerations in biosimilars: Asia pacific regions
Published in Preparative Biochemistry & Biotechnology, 2021
Anurag S. Rathore, Ankita Bhargava
In 2013, the Thai Food and Drug Administration (FDA) released their first biosimilar guidelines. The guidelines are in line with WHO standards and The Association of Southeast Asian Nations (ASEAN) harmonization. The Thai FDA defines a “biological product” as “any allergen, antigen, vaccine, hormone, cytokine, enzyme, product derived from stem cells or tissues, human whole blood and plasma derivative, therapeutic serum, immunoglobulin, or monoclonal antibody.” These guidelines specify the need for information on the molecule, its manufacturing process, and comparative physiochemical characterization between the biosimilar and biologic.[15] The Thai FDA published the notification on the market authorization drug registration dossiers for biosimilars in 2013. An applicant has to include the following information in drug registration dossiers:[16]The biological substance, its manufacturing process, and the comparative physicochemical characterization between the biosimilar and the reference biological product (RBP) (e.g., molecular similarity, structural analyses, etc.).Non-clinical and clinical trial data of comparison studies between the biosimilar and RBP.A risk management plan (RMP)
Risk management framework for outsourcing in the defence sector: a case from India
Published in International Journal of Production Research, 2019
Nilesh Perlekar, Jitesh J. Thakkar
In this research, Grey FMEA is used to develop risk management plan for outsourcing in a defence sector organisation. In framework, the risk categories and sub-categories are finalised by the literature survey and two-phase procedure of expert’s interview and group discussions. Grey FMEA is used to analyse the associated risks. After finalisation of template of FMEA document and list of categories and sub-categories, the ratings of severity, occurrence and detection are collected from the experts in the form of subjective grading. Furthermore, these subjective ratings are converted into crisp value and finally Risk Priority Number is calculated to rank the risks. Inferences are drawn by using both mathematical and graphical analyses. A detailed risk mitigation procedure is developed to provide a ten-point action plan, as per the expert’s requirements. The experts are found satisfied with the risk management framework used in the research and accept its practical applicability.
Characterizing workforces exposed to current and emerging non-carbonaceous nanomaterials in the U.S.
Published in Journal of Occupational and Environmental Hygiene, 2018
Kelsey R. Babik, Matthew M. Dahm, Kevin H. Dunn, Kevin L. Dunn, Mary K. Schubauer-Berigan
While it is difficult to generalize about the appropriate types of exposure controls for each company given that numerous factors can influence control selection, a prudent risk-management approach suggests that steps should be taken to keep exposures as low as possibly achievable until more is known. This can be done through implementing a risk management plan.[42] When controlling potential exposures within a workplace, NIOSH has recommended a hierarchical approach as a means to reduce worker exposures. The basis for the hierarchy of controls is to eliminate the hazard when possible by substituting it with a less hazardous material or, if not feasible, controlling the hazard at or as close to the source as possible through engineering controls. Administrative controls and PPE, including respiratory protection, are to be use, respectively, as final efforts to further reduce exposures.[16,43]