The Medical Devices Introductory Course 2020

5 Analysis

10 Post Production

5.5 Estimate

Act

Plan

Check

Do

9 Review

6 Evaluate

8 Evaluate Overall

7 Control

The Organisation for Professionals in Regulatory Affairs

Common Issues

Identify actual harm

NBs look for consistency with legislation and standard – watch for these issues!

Different severity

• Harms are not defined • Outcomes (harms) are grouped • Causes are not defined • Pre-control estimation not conducted • Detection used inappropriately • Risks not reduced AFAP • No RBA • Report does not meet requirements • No post production feedback • Risk management file not maintained

Different probability

Effectiveness of controls

Under estimate risk

Uncontrolled risk

Must have + benefit

Read clause!

X-ref to PMS

Maintain a risk file

The Organisation for Professionals in Regulatory Affairs