1. Risk analysis – FMEA Workshops

2. FMEA 1 Simple risk assessment process!!  Identifying risk  Simple method for grading risk  Determines appropriate risk reduction options  Ultimately assesses risk to patient Applications –Equipment, facilities, products and processes Targets areas of concern

3. FMEA 2 1.Severity of Impact  Negligible, minor, major, critical 2.Occurrence of problem  Frequency  Highly unlikely, unlikely, likely, high likely 3.Detection of problem  Easy, can be detected, difficult to detect, undetectable

4. FMEA 3 RPN (Risk Priority Number) calculated RPN – numeric value to risk potential 1.Severity  1-4 (1 is negligible) 2.Occurrence  1-4 (1 is highly unlikely) 3.Detection  1-4 (1 is easily detected) RPN = S x O x D (1-48) 1 – lowest risk to patient / highest GMP compliance

5. FMEA 4 – Risk acceptance RPNDescription Actions required to control process >35Intolerable risk Process re-engineering Additional testing required 20-34Unacceptable risk Must be validated Additional inspections 5-19Tolerable risk Justifications required Evaluate additional tests <5Negligible riskVerification vs validation No additional requirements