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