Module 16 2022

Example: Estimation of Occurrence via PMS Real Life Examples: PMS Defect PMS Reported 2019 Occurrence Rate in RMF Current Residual Risk Revision Required Risk = Severity of Harm (S) x Probability of Occurrence of Harm (POH).

Broken Needle 227PPM ~ 3 2

LOW

YES

306PPM ~ 3 3

MEDIUM NO

Safety Needle Activated Prior to Use

Depended on Severity of No Dose Drug

Value Qualitative Classification

Occurrence Rate X ≤ 1/1’000’000

Note: Failure rate is part of P1 calculation in POH PPM = Part per Million

1 2 3 5

Very low

Low

1/1’000’000 < X ≤ 1/10’000

Moderate

1/10’000 < X ≤ 1/100

High

1/100 < X ≤ 1/10

10 Very high

X > 1/10

27

Business Use Only