RISK MANAGEMENT Flashcards
It is the chance or probability, high at one extreme and low at the other, that a person could be harmed or experience an adverse health outcome if something goes wrong, together with an indication of how serious the harm could be
Risk
It is a written document that details the organization’s risk management process
Risk management
These process starts by creating a team of stakeholders across the organization to review potential risks to the organization
Risk management
Risk management involves
Having the necessary systems, processes, and skilled stuff in place the minimize the likelihood of providing poor quality care
Having mechanisms to learn from situations where despite having those systems something has gone wrong
Identifying and minimizing the potential for harm or adverse health outcomes if something goes wrong as a result of a pharmacy’s activities and services
This is a set of pharmacovigilance activities and interventions designed to identify, characterized, prevent or minimize risk relating to medicinal products including the assessment of the effectiveness of those activities and interventions
Risk management system in pharmacy
Risk management process includes
Set objectives
Risk identification
Risk assessment
Risk analysis
Risk tolerance
Risk mitigation
The team members need to review business objectives, such as product development or third party business partnerships
Set objectives
It is the second step in creating a risk management plan lies in reviewing digital assets such a systems, networks, software, devices, vendors, and data. Cataloging this assets then allows the team members to identify risks to the assets
Risk identification
True or false
A risk or uncertain event can be a positive or negative condition
True
True or false
A risk or uncertain event can be positive or negative condition that do not have a financial operational or reputational impact
False it has a financial operational or reputational impact
After identifying risks, the risk management
team needs to assess the risk. Positive risks,
such as early product delivery, can also lead
to negative risks, such as a customer’s
inability to meet a payment schedule. The
organization needs to foresee risks in order
to find a way to analyze their potential
impact.
Risk Assessment
For each risk identified and assessed, the
team must look at the likelihood the event
will occur and then estimate impacts to the
business if it does occur. Multiplying
likelihood by the estimated impact can give
insight into a risk’s effect.
Risk Analysis
A risk with a low likelihood leads to a
Devastating financial impact
Meanwhile, a risk
with a high likelihood may have
No impact
Part
of the quantitative or qualitative analysis is
creating the
Risk Assessment Matrix
This allows the risk management team to use
the risk analysis and assign ratings such as high,
medium, or low.
Risk Assessment Matrix
Was used to assess the risks identified in the risk universe and prioritize them
Delphi Method
After assigning risk ratings, the team works
to determine whether it will accept, transfer,
mitigate, or refuse a risk.
Risk Tolerance
The team may decide to accept a ______ potential event that is not likely to occur and
would have little impact if it did; however,
they may also choose to refuse a ________
potential event that is highly likely to occur
and would have a large impact.
Low-risk
High-risk
For accepted risks, the team must create a set of risk mitigation strategies. For every
risk that an organization accepts or
transfers, it needs to define responses to
issues that can occur.
Risk Mitigation
this means setting controls to
protect data from cybercriminals.
Risk Mitigation in Information Security
Thus, the risk mitigation strategies act as a
_______ in case the event occurs to
help limit the defined impact.
Contingency plan
Administrative Order 2014-0034
Rules and Regulations on the Licensing of Establishments Engaged in the Manufacture, Conduct of Clinical Trial, Distribution, Importation, Exportation, and Retailing of Drug Products, and Issuance of Other Related Authorization
Rules and Regulations on the Licensing of Establishments Engaged in the Manufacture, Conduct of Clinical Trial, Distribution, Importation, Exportation, and Retailing of Drug Products, and Issuance of Other Related Authorization
Administrative Order 2014-0034
Section V-General Guidelines
All establishments are required to implement a risk management plan which is a requirement for the issuance of an LTO or other authorization.
All establishments are required to implement a risk management plan which is a requirement for the issuance of an LTO or other authorization.
Section V - General Guidelines
FDA Circular 2018 - 013
The objective of this FDA Circular is to provide guidance on the preparation of an RMP as part of the FDA’s requirements for the issuance of a License to Operate (LTO).
The objective of this FDA Circular is to provide guidance on the preparation of an RMP as part of the FDA’s requirements for the issuance of a License to Operate (LTO).
FDA Circular 2018 -013
ISO 31000 : 2018
Risk Management - Guidelines
Provides guidelines on managing risk faced by organizations
Provides a common approach to managing any type of risk
Provides guidelines on managing risk faced by organizations
Provides a common approach to managing any type of risk
ISO 31000 : 2018
Risk Management - Guidelines
