Biomedical Engineering Reference
In-Depth Information
Quality by design
approach
Traditional
approach
Control strategy
based on
traditional
specification
setting
Control strategy
based on criticality
assessment of
variables
Knowledge space and
quality systems support
risk-based control
strategy?
No
Yes
Risk assessment:
* Comparison of NOR and PARs
* Knowledge of equipment capabilities
No
Potential for variables to
impact product quality?
Non-critical parameter
Low risk
High risk
Yes
Low risk
Risk assessment:
* Relationship of NOR to PAR
* Knowledge of edge of failure
* Process robustness
* Established control strategy
* Understanding of multivariate relationships
High risk
Critical parameter
Increased process understanding/knowledge
Figure 8.5
Decision tree for evaluation of CPPs using risk assessments.
196
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