RISK MANAGEMENT Flashcards

1
Q

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.

A

Risk

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2
Q

It is a written document that details the organization’s risk management process. This process starts by creating a team of stakeholders across the organization to review potential risks to the organization.

A

Risk Management

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3
Q

Risk management inloves having the necessary systems, processes, and skilled staff in place to minimize the likelihood of providing ____ quality care.

A

poor

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4
Q

Risk management involves having _______ to learn from situations where despite having those systems something has gone wrong.

A

mechanisms

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5
Q

Risk management involves identifying and minimizing the ______ for harm or adverse health outcomes if something goes wrong as a result of a pharmacy’s activities and services

A

potential

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6
Q

This is a set of pharmacovigilance activities and interventions designed to identify, characterize, prevent or minimize risks relating to medicinal products including the assessment of the effectiveness of those activities and interventions.

A

Risk Management System in Pharmacy

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7
Q

Risk Management Process

A
  1. Set Objectives
  2. Risk Identification
  3. Risk Assessment
  4. Risk Analysis
  5. Risk Tolerance
  6. Risk Mitigation
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8
Q

First, the team members need to review business objectives, such as product development or third-party business partnerships. By starting with business objectives, the risk management process aligns with current as well as future goals.

A

Set Objectives

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9
Q

The second step in creating a risk management plan lies in reviewing digital assets such as systems, networks, software, devices, vendors, and data. Cataloging these assets then allows the team members to identify risks to the assets.

A

Risk Identification

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10
Q

A risk, or ______ event, can be a positive or negative condition that has a financial, operational, or reputational impact.

A

uncertain

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11
Q

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.

A

Risk Assessment

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12
Q

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.

A

Risk Analysis

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13
Q

A risk with a ___ likelihood leads to a devastating financial impact. Meanwhile, a risk with a ____ 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.

A

low - devastating financial impact
high - no impact

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14
Q

___________ was used to assess the risks identified in the risk universe and prioritize them.

A

Delphi method

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15
Q

After assigning risk ratings, the team works to determine whether it will accept, transfer, mitigate, or refuse a risk.

A

Risk Tolerance

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16
Q

The team may decide to accept a low-risk potential event that is not likely to occur and would have little impact if it did; however, they may also choose to refuse a high-risk potential event that is highly likely to occur and would have a large impact.

A

Risk Tolerance

17
Q

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. In information security, this means setting controls to protect data from cybercriminals.

A

Risk Mitigation

18
Q

Thus, the risk mitigation strategies act as a ____________ in case the event occurs to help limit the defined impact.

A

contingency plan

19
Q

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 Authorizations

A

Administrative Order 2014-0034

20
Q

All establishments are required to implement a risk management plan which is a requirement for the issuance of an LTO or other authorization.

A

Section V - General Guidelines

21
Q

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).

A

FDA CIRCULAR 2018-013

22
Q

Provides guidelines on managing risk faced by organizations.

A

ISO 31000:2018

23
Q

Provides a common approach to managing any type of risk.

A

ISO 31000:2018