Quality Risk Management

Question 1

combination of the probability of occurrence of harm and the severity of that harm

Answer 1

Risk

Question 2

Severity levels

Answer 2

Low, medium, high, catastrophic

Question 3

Definition of risk

Answer 3

exposed to danger

Question 4

Systematic process for the assessment control, communication and review of risks to the quality of the drug (medicinal) product across the product lifecycle

Answer 4

Management

Question 5

defined as the process of identifying, monitoring and managing potential risks in order to minimize the negative impact they may have on an organization.

Answer 5

Risk Management

Question 6

are increasingly seen as a valuable component of Quality System which empowers the industry to meet those challenges.

Answer 6

Risk management principles

Question 7

Risk is a cognitive and emotional response to expected loss

Answer 7

Individuals

Question 8

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

Answer 8

Technicians

Question 9

Formula

Answer 9

Expected Value = Probability of Event * Consequences of Event

Question 10

Combination of the probability of occurrence of harm and the severity of that harm

Answer 10

ICHQ9

Question 11

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.

Answer 11

International Council for Harmonisation

Question 12

The evaluation of the risk to quality should be based on what

Answer 12

scientific knowledge and ultimately link to the protection of the patient

Question 13

a risk which has chance of loss or no loss. Covered by insurance.

Answer 13

Pure risk

Question 14

Involves chance of gain/loss.

Answer 14

Speculative risk-

Question 15

Involves chance of gain/loss.

Answer 15

Speculative risk-

Question 16

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.

Answer 16

Fundamental risk

Question 17

These are project specific risks and are identified within the parameters of a project and can be controlled during the implementation of a project.

Answer 17

Particular risk

Question 18

Advantages of Applying QRM.

Answer 18

Improve
● Reduces subjectivity

● Allows prioritization through Risk Ranking

Question 19

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

Answer 19

Risk identification

Question 20

second stage in the risk management process where collated data is analyzed for potential risks

Answer 20

Risk assessment

Question 21

second stage in the risk management process where collated data is analyzed for potential risks

Answer 21

Risk assessment

Question 22

Risk assessment consists of what?

Answer 22

qualitative risk assessment and quantitative risk assessment

Question 23

Used to visually represent the likelihood and impact of each risk.

Answer 23

Risk matrix

Question 24

will be in the form of mitigation by adopting necessary strategies in respect of positive and negative risks which is furnished below

Answer 24

Risk response planning

Question 25

Risk assessment

Answer 25

Risk Identification

Risk Analysis

Risk Evaluation

Question 26

Monitoring and Controlling of Risk

Answer 26

Continuous monitoring

Risk mitigation

Risk transfer

Question 27

Need to assess all probable risks. Theoretical risk should be considered, but only formally addressed through risk assessment if they carry extraordinary patient safety or regulatory compliance significance.

Answer 27

Balance

Question 28

Risk Reduction Concepts

Answer 28

ALARP

Question 29

ALA

Answer 29

As low as

Question 30

RP

Answer 30

Reasonably practicable

Question 31

RP

Answer 31

Reasonably practicable

Question 32

This part of the acronym emphasizes the objective of reducing risks to the lowest possible level.

Answer 32

ALA

Question 33

This part recognizes that there are practical and economic limits to risk reduction. It means that you should take all feasible measures to reduce risks but within the bounds of what is considered reasonable, both in terms of cost and effort.

Answer 33

Reasonably Practicable

Question 34

Have been assessed and risks that have been accepted
Have been identified but the risks have not been correctly assessed
‘leftover risk”

Answer 34

Residual Risk

Question 35

must decide if residual risks are acceptable

Answer 35

Manufacturer

Question 36

means that the process of managing risks does not guarantee
complete removal or elimination of all risks.

Answer 36

Risk management ≠ risk elimination

Question 37

means that the process of managing risks does not guarantee
complete removal or elimination of all risks.

Answer 37

Risk management ≠ risk elimination