Not Sure if This Is a Quality Event?
Quality Events are used to document situations that may impact product quality,
data integrity, compliance, or GMP expectations.
If you are unsure whether something should be reported as a Quality Event,
use the guidance below.
Common examples include:
- Unexpected results, errors, or deviations from expected processes
- Documentation mistakes or missing information
- Equipment issues that could affect quality
- Material identification, handling, or labeling concerns
- Anything that “doesn’t seem right” from a quality perspective
When in doubt, submit a Quality Event.
Submitting an event does not assign blame and does not mean a CAPA will be required.
Quality Assurance will review and determine appropriate next steps.
What happens after submission?
Quality Assurance will review the information, assess risk, and determine
whether further investigation or action is needed.
Not every Quality Event results in a deviation or CAPA.