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Project Management > Risk Assessment > Flashcards

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
Q

Why is risk management necessary in project

A

ISO risk Management Guidelines

26
Q

which tools are used in RM?

know how to do it

A

Failure Mode and Effect Analysis (FMEA)

27
Q

what are the four strategies for dealing with risks?

A

Avoid, mitigate, accept and tranfer risks

28
Q

What are the steps in the RS?

A

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
Q

what is the risk register

A

is the document containing the results of RM
must be continuously updated
must always be marked with version number and date of creation

30
Q

When and who is involved in RM?

A

RM is a continuous process in the project, which is the responsibility of the risk manager

31
Q

Which guidelines are used for RM?

A

ICH Q8: Pharmceutical Development
ICH Q9: Quality Risk Managment
ICH Q10: Pharmaceutical Quality System
ICH Q11: Development and Manufacture of DS

32
Q

Scope of ICH Q9?

A

Systematic approach

provides principles and examples of tools for quality risk managemnet

33
Q

what are the two primary principles of the QRM?

A

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
Q

What is the QRM?

A

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
Q

Risk assessment consists of?

A

identification of hazards

anylsis and evalution of risk

36
Q

draw the quality risk evaluation pyramid

A

do you know it?

37
Q

What is risk identification?

A

is a systematic use of information to identify hazards

38
Q

Risk analysis?

A

is the estimation of the risk associated with the identified hazards (qualitative or quantitative process

39
Q

Risk evaluation

A

it compared the identified and analyzed risk against given risk criteria

40
Q

risk control includes?

A

decision making to reduce (to an accetable level) and /or accept risk

41
Q

what is part of the risk control strategy?

A

reduction measures for mitigation or avoidance

42
Q

Risk communication?

A

is the hsaring of information about risk and RM

43
Q

Basic risk management facilitation methods?

A

Flow charts
check sheets
process mapping
Ishikawa diagram

44
Q

RM tool?

A

FMEA
FMECA
FTA
HACCP

45
Q

Supporting statistical tools?

A

control chart
DoE
Process Capability anaylsis

Project Management (6 decks)

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