Risk Assessment Flashcards

1
Q

Five key stages in PM?

A
defining the project
creating the project strategy
detailed project planning
implementation and control
Review and learning
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2
Q

SWOT analysis

A

identifies strength, weakesses, opportunities and threats

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3
Q

SWOT analysis check what?

A

both the internal and external environment

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4
Q

what are strength and weaknesses?

A

controllable internal factors and can be changed

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5
Q

what are opportunities and threats?

A

uncontrollable external factors in the future and cannot be change

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6
Q

Questions to ask for strength?

A

What is going well? What can we rely on?
What satisfies us? Where do we get the energy from? What are
we proud of? What are our strengths?

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7
Q

Questions to ask for weaknesses?

A

What is difficult? Which disturbances hinder us? What is

missing? What is difficult for us? Where are our traps?

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8
Q

Questions to ask for opportunities?

A

What opportunities are opening up for us?
Which market segments will boom? What can we use in our
environment? What lies fallow? What is expandable?

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9
Q

Questions to ask for threats?

A


Where are the dangers lurking? What difficulties are we
facing? What must we expect? What are our fears?

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10
Q

Questions on the concretisation of SWOT strategies? S-O

A

Which opportunities can be used with the current strengths?

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11
Q

Questions on the concretisation of SWOT strategies? S-T

A

Which threats can be eliminated or reduced with

our current strengths?

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12
Q

Questions on the concretisation of SWOT strategies? W-O

A

Which opportunities can
be used if our current weakness has been
eliminated?

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13
Q

Questions on the concretisation of SWOT strategies? W-T

A

Which threats can be
banned if we eliminate our
current weakness?

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14
Q

Risk Management definition?

A

identifying the uncertainties in the planning of prject activities and their implementation

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15
Q

What are uncertainties?

A

Uncertainty is an unavoidable. characteristic feature of projects

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16
Q

qualitatie uncertainty analysis tool in project options and strategies phase? (know how to draw them)

A

Urgency-imprtance grid
Uncertainty-importance grid
Risk matrix
Uncertainty tunnel

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17
Q

which numerical methods can be used in the uncertainty analysis

A

use of decision-tree methodology (Monte Carlo methods)

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18
Q

in which area can the Monte carlo method be used?

A

drug efficiency, costs of drug development, time to market, penetration of market, drug price

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19
Q

how does the DIN EN 62198 defined project risk?

A

as the combination of the probability of a certain event occurring and its consequences for the project objectives

20
Q

What are the 5 consecutive activites in a RMP?

A
  1. Risk identification
  2. Risk Assessment
  3. Risk treatment
  4. Recourse to a catalgue of measures
  5. Risk monitoring
21
Q

What is a risk?

A

The effect of uncertainty on goals, eading to a deviation from the expectations in both positive and negative respects

22
Q

What is risk managment in the project?

A

Systematic risk management endeavours to actively minimise the dangers

23
Q

Risk owner?

A

the person responsible for monitoring th risk and eciding on an appropriate risk management strategy

24
Q

Possible risk in a projects are?

A

product life cycle, Business risks, product risks and projects risks

25
Why is risk management necessary in project
ISO risk Management Guidelines
26
which tools are used in RM? | know how to do it
Failure Mode and Effect Analysis (FMEA)
27
what are the four strategies for dealing with risks?
Avoid, mitigate, accept and tranfer risks
28
What are the steps in the RS?
Plan, evaluate and selct risk measures Steady risk measures and risk management in the course of the project Learning from risks The risk register
29
what is the risk register
is the document containing the results of RM must be continuously updated must always be marked with version number and date of creation
30
When and who is involved in RM?
RM is a continuous process in the project, which is the responsibility of the risk manager
31
Which guidelines are used for RM?
ICH Q8: Pharmceutical Development ICH Q9: Quality Risk Managment ICH Q10: Pharmaceutical Quality System ICH Q11: Development and Manufacture of DS
32
Scope of ICH Q9?
Systematic approach | provides principles and examples of tools for quality risk managemnet
33
what are the two primary principles of the QRM?
Evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient Level of effort , formality and documentation of the quality risk management process should be commensurate with the level of risk
34
What is the QRM?
it is a systematic process for assessment,control, communication and review of risk to the quality of the drug product across the product lifecycle
35
Risk assessment consists of?
identification of hazards | anylsis and evalution of risk
36
draw the quality risk evaluation pyramid
do you know it?
37
What is risk identification?
is a systematic use of information to identify hazards
38
Risk analysis?
is the estimation of the risk associated with the identified hazards (qualitative or quantitative process
39
Risk evaluation
it compared the identified and analyzed risk against given risk criteria
40
risk control includes?
decision making to reduce (to an accetable level) and /or accept risk
41
what is part of the risk control strategy?
reduction measures for mitigation or avoidance
42
Risk communication?
is the hsaring of information about risk and RM
43
Basic risk management facilitation methods?
Flow charts check sheets process mapping Ishikawa diagram
44
RM tool?
FMEA FMECA FTA HACCP
45
Supporting statistical tools?
control chart DoE Process Capability anaylsis