Tuesday, September 19, 2017
Project co-funded by the European Commission in the framework of the 2nd Health Programme
Risk assessment Minimize

35.  What is risk management as defined in the EU GTP?

 

o

A financial investigation

o

The overall quality management process by which risks are identified, evaluated, controlled, monitored and reviewed.

o

A regulatory requirement for TE’s

o

Investigating and documenting that a process or system meets its pre-determined specifications and quality attributes

 

 

 

 

 

 

36. Which formula for Risk management is applicable according to the EU GTP?

 

o

Risk = severity x probability (x detectability)

o

Risk = severity x costs

o

Risk = severity x demonstrability

o

Risk = severity x solvability

 

 

37. Ideally, who should be involved in performing a risk assessment?

 

o

The quality manager

o

Process owner(s), possibly multidiscplinary

o

One process owner

o

Process owner(s) and quality manager

 

38. How often does a risk assessment should be done?

 

o

One time, to establish the process the risk assessment is done to

o

Every year

o

Every three years

o

Depends on the process changes and evaluation of the previous risk assessment

 

 

39. What can risk assessment provide for a TE? More answers possible

o

A rationale for decisions on safety and quality of the primary processes

o

Be compliant to the EU directive

o

An evaluation of what still has to be validated

o

Teambuilding

 

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