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level: Level 1

Questions and Answers List

level questions: Level 1

Question	Answer
Are effectively utilized in many areas of business and government including finance, insurance, occupational safety, public health, pharmacovigilance, and by agencies regulating these industries. In the Pharmaceutical field, it is limited and do not represent full contributions. But recently, it became evident that it is a valuable component of an effective quality system	Risk Management Principles
Is defined as the combination of the probability of occurrence of harm and the severity of that harm.	Risk
The manufacturing and use of a drug (medicinal) product, including its components, necessarily entail some degree of risk. TRUE OR FALSE	TRUE
Effective Risk Management Approach:	1 High Quality Product 2 Improved decision-making if a quality problem arises. 3 Can provide regulators with greater assurance of a company’s ability to deal with potential risks 4 Beneficially affect the extent and level of direct regulatory oversight.
TWO PRIMARY PRINCIPLES of quality risk management are:	1 The evaluation of the risk to quality should be based on SCIENTIFIC KNOWLEDGE and ultimately link to the protection of the patient 2 The level of effort, formality and documentation of the quality risk management process should be IN PROPORTION with the level of risk
is a systematic process for the assessment, control, communication and review of risks to the quality of the drug (medicinal) product across the product lifecycle	Quality Risk Management
RESPONSIBILITIES in Risk Management: Decision makers should: __	1. Take responsibility for coordinating quality risk management across various functions and departments of their organization; and 2. Assure that a quality risk management process is defined, deployed and reviewed and that adequate resources are available.
It consists of the identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards.	Risk Assessment
As an aid to clearly defining the risk(s) for risk assessment purposes, three fundamental questions are often helpful:	1 What might go wrong? 2 What is the likelihood (probability) it will go wrong? 3 What are the consequences (severity)?
It is a systematic use of information to identify hazards referring to the risk question or problem description. It addresses the “What might go wrong?” question, including identifying the possible consequences.	Risk Identification Information include: - historical data, - theoretical analysis, - informed opinions; and - the concerns of stakeholders.
It is the ESTIMATION of the risk associated with the identified hazards. It is the qualitative or quantitative process of linking the likelihood of occurrence and severity of harms.	Risk Analysis
It compares the identified and analyzed risk against given risk criteria. It consider the strength of evidence for all three of the fundamental questions.	Risk Evaluation
It includes decision making to reduce and/or accept risks. The purpose of it is to reduce the risk to an acceptable level. The amount of effort used for it should be proportional to the significance of the risk.	Risk Control
Risk control might focus on the following questions:	1 Is the risk above an acceptable level? 2 What can be done to reduce or eliminate risks? 3 What is the appropriate balance among benefits, risks and resources? 4 Are new risks introduced as a result of the identified risks being controlled?