Objectives

▪ Simplify Quality Event/Incident procedures

▪ Remove subjectivity from escalation

▪ Redefine what constitutes Incidents

▪ Minimize time spent on the documentation of occurrences that have little to no impact on

overall quality

▪ Empower employees
Quality Incidents (QIs)

▪ Quality Incident*: an event or occurrence that directly impacts the ISQP of a product,

safety of employee or patient, and/or integrity of the company, provided that it cannot

be corrected upon discovery

▪ Temperature Excursion Event: temperature readings that have gone out of range

*Deviations from approved processes that do not fall into the QI parameters and cannot be corrected upon discovery will be

addressed and handled outside of the QI system. A memo will be filed in the event that the occurrence cannot be noted

elsewhere (e.g., packaging documentation, logbooks).

Memo Tracking

Auto-generated number, unique to country and year issued

Documents that were deviated from, as applicable

Description of what occurred and what actions were taken

Quality Incident Workflow
Temperature Excursion Workflow