Risk analysis – FMEA
description
Transcript of Risk analysis – FMEA
![Page 1: Risk analysis – FMEA](https://reader036.fdocuments.us/reader036/viewer/2022082213/56814de5550346895dbb54f6/html5/thumbnails/1.jpg)
Risk analysis – FMEA
Workshops
![Page 2: Risk analysis – FMEA](https://reader036.fdocuments.us/reader036/viewer/2022082213/56814de5550346895dbb54f6/html5/thumbnails/2.jpg)
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
![Page 3: Risk analysis – FMEA](https://reader036.fdocuments.us/reader036/viewer/2022082213/56814de5550346895dbb54f6/html5/thumbnails/3.jpg)
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
![Page 4: Risk analysis – FMEA](https://reader036.fdocuments.us/reader036/viewer/2022082213/56814de5550346895dbb54f6/html5/thumbnails/4.jpg)
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
![Page 5: Risk analysis – FMEA](https://reader036.fdocuments.us/reader036/viewer/2022082213/56814de5550346895dbb54f6/html5/thumbnails/5.jpg)
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
![Page 6: Risk analysis – FMEA](https://reader036.fdocuments.us/reader036/viewer/2022082213/56814de5550346895dbb54f6/html5/thumbnails/6.jpg)