Positive Allergen Test Result Procedure
Does anyone have a laid out procedure on what to do if you receive a positive allergen test result on in-house allergen testing? A root cause analysis/investigation/corrective action report template maybe?
Do you mean for environmental monitoring or for finished product?
- Stop production until source is identified.
- Place any suspected contaminated ingredient or product on hold.
- Investigate source: improper sanitation, ingredient contamination, personnel contamination, etc
- Corrective action based on root cause: reclean equipment, retraining, recall, ask supplier for corrective action, etc
- Assess status of on hold product/ingredient. Only release product you are 100% sure is uncontaminated.
- Depending on severity/issue, contaminated product or ingredient may be relabeled with the allergen of contamination or reworked. Though again, if you are selling something milk-free, DO NOT rework milk-contaminated product into that. Only into other things containing milk.
Basically just follow standard CAPA procedures.
Oh and of course document everything.
Do you mean for environmental monitoring or for finished product?
For finished product. Thanks! :)
You've gotten good advice already, but I'll just add:
Get in touch with whoever sells you the kits and ask them to help you troubleshoot!
On the one hand: if you've been using a particular test kit uneventfully and suddenly you get a positive result, it's probably because you have a contamination issue.
On the other: sometimes something else is going on. A quick conversation with your vendor is usually worthwhile.