Quality Risk Management Flashcards
combination of the probability of occurrence of harm and the severity of that harm
Risk
Severity levels
Low, medium, high, catastrophic
Definition of risk
exposed to danger
Systematic process for the assessment control, communication and review of risks to the quality of the drug (medicinal) product across the product lifecycle
Management
defined as the process of identifying, monitoring and managing potential risks in order to minimize the negative impact they may have on an organization.
Risk Management
are increasingly seen as a valuable component of Quality System which empowers the industry to meet those challenges.
Risk management principles
Risk is a cognitive and emotional response to expected loss
Individuals
Risk is usually based on the expected value of the conditional probability of the event occurring multiplied by the consequences of the event given that is has occurred
Technicians
Formula
Expected Value = Probability of Event * Consequences of Event
Combination of the probability of occurrence of harm and the severity of that harm
ICHQ9
issued by the International Council for Harmonisation (ICH) that provides guidance on the application of risk-based thinking to quality management in the pharmaceutical industry.
International Council for Harmonisation
The evaluation of the risk to quality should be based on what
scientific knowledge and ultimately link to the protection of the patient
a risk which has chance of loss or no loss. Covered by insurance.
Pure risk
Involves chance of gain/loss.
Speculative risk-
Involves chance of gain/loss.
Speculative risk-
These are external to a project and which, if they materialize, would be on a large scale and cannot be prevented. These risks are associated with major natural, economic, political or social changes and generate large scale losses. This risk may or may not be insurable.
Fundamental risk
These are project specific risks and are identified within the parameters of a project and can be controlled during the implementation of a project.
Particular risk
Advantages of Applying QRM.
Improve
● Reduces subjectivity
● Allows prioritization through Risk Ranking
the first step in the risk management process is usually
informal and is performed in various ways, depending on the organization and the project team
Risk identification
second stage in the risk management process where collated data is analyzed for potential risks
Risk assessment
second stage in the risk management process where collated data is analyzed for potential risks
Risk assessment
Risk assessment consists of what?
qualitative risk assessment and quantitative risk assessment
Used to visually represent the likelihood and impact of each risk.
Risk matrix
will be in the form of mitigation by adopting necessary strategies in respect of positive and negative risks which is furnished below
Risk response planning
