Module 16 2024

17/10/2024

Corrective and preventative action

Article 83 (3) – Data gathered by the manufacturer's post-market surveillance system shall in particular be used:

(e) for the identification of needs for preventive, corrective or field safety corrective action ;

CORRECTIVE ACTION – Actions taken to prevent recurrence of an incident (Reactive)

PREVENTATIVE ACTION – Actions taken to prevent occurrence of an incident (Pro-active)

It is better to prevent than correct!

© NAMSA 2023 | 23

23

Corrective and preventative action

Types of corrective/preventative action:

• Design changes

• Manufacturing/production process changes

• Labelling and/or instruction for use changes

• Training (design engineers, production staff, users, patients)

• Product upgrades

• Product recall/replacement

• Changes to service/maintenance plans

• Permanent removal of the product from the market

• Changes to the intended purpose or indications for use

• Impact analysis on other devices/products

© NAMSA 2023 | 24

24

12