Engineering CoP TRAs

Front

What is the primary purpose of a Technical Risk Assessment (TRA)?

Back

to identify and mitigate technical and operational risks

Front

Is the Operation TRA equipment independent?

Back

False

Front

Which of the following is a key output of a TRA ?
Options: Feedback Summary, Process parameters and attributes, Product Control Strategy (PCS), Process Definition Diagram (PDD)

Back

Product Control Strategy (PCS)

Front

The QbD TRA is the required input into the Operational TRA

Back

True

Front

What does the Quality by Design (QbD) TRA focus on? Options: Process parameter and attributes, Equipment specific factors, Product Control Strategy (PCS), Critical Quality Attributes (CQAs)

Back

Process parameter and attributes

Front

How many key steps are there in the TRA process ?

Back

6

Front

The TRA process should be reviewed regularly throughout the product lifecycle

Back

True

Front

Which tool is used during the Risk Identification step of the TRA process? Options: Failure mode and effects analysis (FMEA), Product Control Strategy (PCS), Process Definition Diagram (PDD), Formulation Scope

Back

Process Definition Diagram (PDD)

Front

What are 2 out of 6 of the key steps in the TRA process? Options: Analysing of equipment, Analyse formulations, Risk Evaluation and Analysis, Parameter Assessments

Back

Risk Evaluation and Analysis