When a batch of gummy supplements fails quality standards, you don't get a do-over. Instead, you get a Quality Deviation—a formal, non-negotiable procedure. At KorNutra, we isolate, assess, and resolve the issue before any product ships. Here's how it works.
Immediate Containment and Isolation
First thing: quarantine the entire batch. No exceptions. That means:
- Physically segregating every unit in a designated "Hold" area.
- Updating inventory systems so nothing ships or moves further.
- Flagging any in-process materials or finished goods from related lots that might be affected.
Root Cause Investigation and Documentation
Our QA team runs a formal investigation to find out what went wrong. The process:
- Review batch records—raw material receipt through manufacturing, packaging, testing—everything.
- Retest to confirm the failure.
- Audit the process: equipment calibration, operator procedures, environmental conditions at the time of production.
- Check with the supplier if the issue traces back to a raw material.
Every finding goes into a Non-Conformance Report (NCR). No shortcuts.
Corrective and Preventive Actions (CAPA)
Once we know the root cause, we put a CAPA plan in place. Corrective Actions fix the immediate problem with that batch. Preventive Actions make sure it doesn't happen again—updating SOPs, retraining staff, tweaking equipment, or re-evaluating suppliers. We don't just patch; we prevent.
Final Disposition of the Batch
The quarantined batch has a few possible fates, depending on how bad the failure is:
- Rejection and Destruction—the most common outcome for a critical failure. The batch gets formally rejected and disposed of per environmental regs.
- Re-processing—rare, only if scientifically justified and allowed under GMP. The batch gets reworked to meet specs.
- Release for a Different Use—extremely rare. If the failure is purely cosmetic or non-critical, the batch might get used internally or for another approved purpose, not for sale.
Communication and Record Keeping
Key stakeholders are kept in the loop throughout. And we keep a complete, auditable record of the whole event—from the initial failure to final disposition and CAPA verification. That transparency is a cornerstone of our quality system and our promise to deliver products you can trust.