Module 16 2022

EPRs & Control Strategy - Risk-based decision tree (Example)

Essential Performace Requirement other critical attribute

Risk & Process/ Product understanding

Risk & Process / product understanding

high risk / little understanding

Low risk / good understanding

Medium / high risk & little understanding

Low risk / good understanding

No (obligatory) routine testing

Routine Testing on Quality Attribute

Routine Testing on Upstream

Business use only 30