Page 70 - Merchandiser Refresher Course

Identification, Collection and Reporting of Product Quality Complaints

What is a Product Quality Complaint?

• Any complaint in which a Consumer alleges deficiencies with the quality, durability, safety or
intended performance of a product after it is released for distribution.

• It includes concerns about the design, labeling and instructions for use of the product,
packaging (including artwork) or physical appearance of the J&J product.

NOTE: It is important to note that not all PQCs involve a patient or consumer.

When Should I report it?

24 hours = 1 calendar day. Weekends and holidays are included!

Why Should I Report in 24 Hours?

To meet Legal Requirements

• Many Health Authorities require that they be informed of certain reportable events regardless of

where in the world they occurred or where the products were manufactured.
• The reporting process is time-sensitive and requires many steps before reaching the appropriate
Health Authority.

• The Regulatory clock for reporting timelines begins the day the first J&J employee, relevant
contractor or consultant learns of the complaint.