Module 19 2021

02/06/2021

Practical Implementation

Use tools appropriate to device and approach  Preliminary Hazard Analysis (PHA)  Fault Tree Analysis (FTA)  Failure Mode and Effects Analysis (FMEA)  Hazard and Operability (HAZOP)  Hazard Analysis and Critical Control Point (HACCP)  Other....

A

F

G

B

E

H

I

C D

Use more than one approach...

25

Practical Implementation

Use of Fault Log  Non Conformances

 Customer Complaints  Out of Specifications  QMS metrics (post market surveillance)

Risk estimation needs continuous review and verification

Link risk management to existing QMS processes

26

13