When a batch of gummy supplements fails quality standards, you don't get a do-over. The failure triggers a Quality Deviation: a formal, non-negotiable procedure. At KorNutra, we isolate, assess, and resolve the issue before a single unit ships to a customer.
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.
Under 21 CFR 111.113, quality control must reject a batch that deviates from its specifications unless it approves a disposition. The quarantine holds until quality control records that decision.
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.
We log every finding in 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.
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. We formally reject the batch and dispose of it per environmental regs.
- Re-processing: rare, and allowed only when quality control conducts a material review and approves the reprocessing (21 CFR 111.90). We rework it to meet specs.
- Release for a Different Use: the least common outcome. If the failure is purely cosmetic or non-critical, we might use the batch internally or for another approved purpose, not for sale.
Communication and Record Keeping
We keep key stakeholders in the loop throughout. We also keep a complete, auditable record of the whole event, from the initial failure to final disposition and CAPA verification. Under 21 CFR 111.605, we keep those written records for one year past the shelf-life date when shelf-life dating is used, or for two years from distribution of the last batch. If a failure surfaces after product has shipped, that same record becomes the basis for a recall decision under 21 CFR Part 7, Subpart C. That transparency is part of our quality system and our promise to deliver products you can trust.