Risk analysis – FMEA
description
Transcript of Risk analysis – FMEA
Risk analysis – FMEA
Workshops
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
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
FMEA 3
RPN (Risk Priority Number) calculatedRPN – numeric value to risk potential1. 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
FMEA 4 – Risk acceptance
RPN Description Actions required to control process
>35 Intolerable risk Process re-engineeringAdditional testing required
20-34 Unacceptable risk Must be validatedAdditional inspections
5-19 Tolerable risk Justifications requiredEvaluate additional tests
<5 Negligible risk Verification vs validationNo additional requirements